Ekuvavanyeni ezi nkcazo, abafundi akufuneki bathembele ngokungafanelekanga kwiingxelo ezijonge phambili kunye nolwazi olujonge phambili.INkampani ayithathi naluphi na uxanduva lokuhlaziya iingxelo ezijonge phambili kunye nolwazi olujonge phambili oluqulethwe kolu kukhululwa ngaphandle kokuba kufunwa yimithetho esebenzayo, kubandakanywa ngaphandle komda, iCandelo 5.8(2) leSizwe leSixhobo 51-102 (IziBonelelo zokuDiza ngokuqhubekayo. ).
Abadlali abaphambili abaPhambili abahlalutywayo kwiNgxelo yeMarike Ngaba: Covidien/Medtronic, Masimo, Smiths, CareFusion/BD, Meditech, Nihon Kohden, Mediaid/Opto Circuits, Philips Healthcare, ChoiceMMed, Nonin
Buza ngesaphulelo kwimarike yePulse Oximeter 2018-25 Ingxelo apha: https://www.inforgrowth.com/enquiry/r/335427/global-pulse-oximeter-market-research-report-2
Isicelo se-FDA solwazi olongezelelweyo sifuna uvavanyo lwangaphandle noluzimeleyo lweqela lesithathu lokuhambelana kwe-electromagnetic discharge.I-FDA iphinde yacela idatha eqinisekisa ukukwazi kwesixhobo ukurekhoda ii-ECGs zomgangatho wekliniki olinganayo, xa kuthelekiswa nee-ECG ezirekhodwe kusetyenziswa iipatches zombane ze-ECG eziqhelekileyo kunye neentambo ze-ECG.I-CardioComm inikwe ubuninzi beentsuku ze-180 ukuphendula umhloli we-FDA.Ngelixa iNkampani ijonge ukuphendula kwi-FDA phakathi kweentsuku ezingama-90, uvavanyo oluceliweyo kunye namaxwebhu ngamaqela esithathu akazange avumele impendulo kwi-FDA ukuba igqitywe ngeli xesha.Zonke iimvavanyo zesixhobo ngoku zipasisiwe kwaye iziphumo ziqulunqwe ukuze kuphendulwe kwi-FDA.Iwotshi yokuphonononga i-Substantive Review iyakuqala kwakhona xa i-FDA ifumene kwaye iyamkele impendulo yeNkampani.Ngokusekelwe kumaxesha apapashiweyo e-FDA, iNkampani iprojekthi yokugqitywa okunokwenzeka kwe-510 (k) yokuphononongwa kwesicelo ekupheleni kukaDisemba 2018. Inkampani iphawula ukuba i-FDA inamandla okucela ixesha elingakumbi lokugqiba uphononongo lwabo ngokwengqiqo ye-FDA.
I-Provions247 yiwebhusayithi enenjongo yokuhambisa iindaba ezinxulumene neBitcoin kunye nezinye iinethiwekhi zealtcoin.Isebenza ngababhali kunye nabasebenzi abasebenza nabo abakwiindawo ezininzi kwihlabathi liphela.Sijonge ukwenza umxholo okumgangatho ophezulu wabafundi bethu kwindawo ye-cryptocurrency.Kwi-Provions247, sinikezela ngeendaba zamva nje, amaxabiso, impumelelo kunye nohlalutyo sigxininisa kuluvo lwengcali kunye nenkcazo evela kuluntu lwemali yedijithali.
IHeartCheck™ CardiBeat sisixhobo sokurekhoda se-ECG esicwangcisiweyo seBluetooth esithengiswe yiNkampani.Eyokuqala yayiyiBluetooth HeartCheck™ECG PEN.Njengoko kubonisiwe kushicilelo lweNkampani ngoMeyi 22, 2018, i-app ye-GEMS™ Mobile Smartphone iya kuhambelana nenani lezixhobo zokurekhoda ezingenazingcingo ze-ECG, kubandakanywa izixhobo ezikhokelayo ezingenazingcingo ezili-12 eziya kusebenza ngokuthe ngqo ekubekweni kweliso isigulana kunye neemarike zetelemedicine.
Ke ngoko ukongezelela amacandelo angqubanayo kwishishini lePulse Oximeter kubandakanya amagqabantshintshi emizi-mveliso, iishedyuli, kunye neendlela ezicacileyo.Ikwacacisa imigaqo ebalulekileyo efana nenkampani yePulse Oximeter yoqhagamshelwano malunga neqela leshishini lePulse Oximeter, ulwahlulo, umyalelo wokubonelela ngomlinganiselo, isibonelelo sokuthengisa, iindleko / ixabiso lemveliso yePulse Oximeter, kunye nabathengisi abaphambili.
Isahluko 8: Ikhonkco loShishino, iQhinga lokuXhasa kunye nabaThengi abakwiMilambo ezantsi kubandakanywa ukuBonelelwa kweMathiriyeli eLuhlu kunye nabaThengi abasezantsi
Isicelo se-510 (k) siqalise uPhononongo lwe-Substantive yeentsuku ze-90 yi-FDA ngoJuni 8, 2018. I-FDA icele ulwazi olongezelelweyo kwiNkampani malunga nesixhobo sikaJulayi 27, 2018, esimisa iwashi kwi-Substantive Review time line.Ukubalwa kweentsuku ezingama-90 kuya kuqalisa kwakhona xa i-FDA yamkele impendulo yeNkampani kulwazi olongezelelweyo oluceliweyo.
IiNgxelo zeMarike yeHlabathi liphela yindawo yakho yokugcina enenkcukacha kunye neengxelo ezinzulu zophando lwemarike ezihlanganiswe luluhlu olubanzi lwabapapashi abavela kwihlabathi liphela.Sinikezela ngeengxelo kuzo zonke iindawo kunye noluhlu olupheleleyo lwe-sub-domains phantsi kwelanga.Amagalelo e-WMR aphandwe kakuhle aquka imimandla enza ukuba abathengi bethu abaxabisekileyo baxhamle kumathuba angundoqo okukhula kwaye bakhusele kuzo izoyikiso ezithembekileyo ezixhaphakileyo kwimarike kwimeko yangoku kunye nezo zilindelwe kwikamva elingekude.
Kukho iindidi ezisekelwe kwiintlobo zeemveliso ze-ECG ze-Leadwires Market Market.Iimveliso zifuna ulwazi olunikezwe sisicelo somsebenzisi kwaye ingxelo inedatha kuyo ngokunjalo:
Inkampani iya kubonelela ngohlaziyo koku kunye nakwixesha elizayo 510(k) izicelo.Ukufunda ngakumbi ngeemveliso zeCardioComm kunye nohlaziyo olongezelelweyo malunga neHeartCheck™ ECG edityanisiweyo yesixhobo nceda undwendwele iwebhusayithi yeNkampani ku-www.cardiocommsolutions.com kunye www.theheartcheck.com.Jonga kwiNkampani ngoMeyi 22, 2018 ukhupho losasazo ngolwazi oluthe vetshe malunga nokufakwa kwe-FDA kokuqala.
iintambo ECG kunye ECG leadwires Market |Ubungakanani, iSabelo, uHlumo kunye noQhekelelo luka-2023 |Ividiyo eNxulumene neNcam yeOximeter:
Thatha uxanduva olupheleleyo lokwanelisa zonke iimfuno zabathengi bethu;ukuzuza ukuqhubela phambili okuqhubekayo ngokuvuma ukwanda kwabathengi bethu;jike ube liqabane lokugqibela elisisigxina lentsebenziswano yabathengi kwaye wandise umdla wabathengiPu Umdala Nibp Cuff , Philips M2734b Avalon Toco Maternal Pulse Transducer , Imaski yobuso beNebulizer, Siyazingca ukubonelela ngeemveliso zethu kuwo wonke umlandeli we-auto kwihlabathi jikelele ngeenkonzo zethu eziguquguqukayo, ezikhawulezayo ezisebenzayo kunye nomgangatho ongqongqo wolawulo lomgangatho osoloko uvunywa kwaye unconywa ngabathengi.