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.
KwaMedgadget sinikela ingxelo ngeendaba zetekhnoloji yezonyango zamva nje, iinkokeli zodliwano-ndlebe ebaleni, kunye neefayile ezithunyelwa kwiziganeko zonyango ezivela kwihlabathi liphela.
Kule sifundo, iminyaka ecingelwa ukuba iqikelele ubungakanani beemarike ze-Global ECG cables kunye ne-ECG leadwires zimi ngolu hlobo lulandelayo: Unyaka weMbali: I-2013-2017 Unyaka weSiseko: Unyaka oqikelelweyo we-2017: I-2018 Forecast Year 2018 ukuya kwi-2025
Imimandla emikhulu yeUnited States Pulse Oximeter Systems Industry zilandelayo: eJamani, France, UK, Russia, Italy, Spain, Benelux
Ukhuphiswano lweCerebral Oximetry Monitoring yemarike ngabavelisi abaphambili/ Umdlali ophambili/ uQoqosho ngabaNkokheli boShishino: Medtronic, Philips Healthcare, Masimo, GE Healthcare, Edwards Lifesciences, Mindray Medical, Natus Medical, Honeywell Life Sciences, Welch Allyn, Omron Healthcare, Nihon Kohden, Spacelabs Ukhathalelo lwempilo, iSt. Jude Medical, iNonin Medical, iBoston Scientific, ,.Kunye nokuninzi……
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.
Khuphela incwadana yePDF yeCable Cable kunye neECG yeNgxelo yoPhando lweMakethi yoPhando lweeNcingo eziKhokela kwi-ECG @ https://www.coherentmarketinsights.com/insight/request-pdf/957
Ngeli xesha, imvume evela kwi-FDA eyabhengezwa ngu-Apple ngolwesiThathu ihambelana nezinto ezimbini: Okokuqala kukuba iwotshi inokubeka iliso entliziyweni yakho ngesingqi esingaqhelekanga kwaye ikhuphe izilumkiso ukuba kwaye xa izibona - eli nqaku liyafumaneka kuzo zonke iimodeli ze-Apple Watch ezithandanayo. buyela kweyokuqala.
Uphononongo lophando lubandakanya abaqhubi bemarike, abakhoyo kunye namathuba azayo okukhula, icandelo lobulumko kunye nemiceli mngeni yobulumko yengingqi ejongene ne-ECG Cable kunye ne-ECG ye-Lead Wire market, imeko yokhuphiswano kwimarike yehlabathi.Imeko yengingqi yengxelo igubungela ubungakanani bemarike kunye nokuthelekisa imimandla eyile, uMntla Merika, iYurophu, iAsia Pacific (APAC), uMbindi Mpuma kunye neAfrika (MEA), kunye neLatin America.
Bendisonwabile ndisitya oku kutya kusisiseko kwimfundo yam yezonyango de ndadibana nomntu ongaqhelekanga.UGary Thomas wandimangalisa ukususela oko ndadibana naye.Utitshala onetalente yezonyango, unokukuthatha kuhambo olusuka kwifiziksi esisiseko ukuya ekunyamekeleni umntwana ogulayo ngokuqhwanyaza kweliso.Ngoxa wayehlaziya iimviwo zokuthomalalisa iintlungu, wandinika uqheliselo lweviva, nto leyo endandikhangele phambili kuyo ngendlela engaqhelekanga.Ndandiziphumelele iimviwo zam, ndiziva ndizithembile ngolwazi lwam, kwaye ndinethemba lokuba ndiza kumchukumisa.Kwiintsuku ezingaphambi kweKrisimesi, ndaya eofisini kaGary kwiseshoni yethu yokuqala.Iyure elandelayo yayiluzizi.Mhlawumbi ndiye ndazivala ngokwasengqondweni ezi ntlungu.Inkumbulo endiyigcinileyo iphendula umbuzo malunga nemingcipheko yeethemometha ngokuthi "Ewe, zinokugqabhuka!"Andizange ndidlale kakubi nje kuphela, kodwa kwakungekho bumnandi besandwich endinokuhlafuna kuyo.“Akwanelanga ukuba ungapasa.Kuya kufuneka wenze umsebenzi omninzi kwaye ngendlela eyahlukileyo ukuba ufuna ukupasa. "“IKrisimesi emyoli kum,” ndacinga njalo.
Imijelo yokuthengisa ekhethiweyo (ebandakanya ukuthengisa ngokuthe ngqo kunye nokungathanga ngqo) ziinkampani zibalwe ngokufutshane kwingxelo.
Imakethi yeSteel Formwork Market ka-2018 ibonisa izinga lokukhula elibalulekileyo kwaye inokuba lelinye lamashishini ebenegalelo ekuzinziseni uqoqosho lwamazwe ngamazwe.…
I-CardioComm Solutions 'HeartCheck (TM) I-CardiBeat kunye ne-Smart Phone App Ngena kwiNqanaba lokugqibela le-FDA 510 (k) Uphononongo |Ividiyo eNxulumene ne-Ecg Leadwires:
Ishishini ligcina ingqikelelo yokusebenza "ulawulo lwesayensi, umgangatho weprimiyamu kunye nokubaluleka kokusebenza kakuhle, ukongamela komthengiUmntwana oLahliweyo oneTube yeNibp Cuff , Sats Probe , Iikliphu ze-Alligator 3.0inaliti kwiTab ye-Adapter yeNkokheli, Ngokusekelwe kwiinjineli ezinamava, zonke ii-odolo zokudweba-based based or sample-based processing ziyamkelwa.Siphumelele igama elihle lenkonzo yabathengi ebalaseleyo phakathi kwabathengi bethu baphesheya.Siza kuqhubeka nokuzama okona kulungileyo ukukunika iimveliso ezisemgangathweni ophezulu kunye nenkonzo engcono.Sijonge phambili ekukhonzeni.