Umugozi wa ECG hamwe na ECG iyobora isoko |Ingano, Gusangira, Gukura no Guteganya kugeza 2023 |Urutoki rwa Oximeter

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Abakinnyi Bakuru Bakuru Basesenguwe Muri Raporo Yisoko Ari: Covidien / Medtronic, Masimo, Smiths, CareFusion / BD, Meditech, Nihon Kohden, Mediaid / Opto Circuit, Ubuvuzi bwa Philips, ChoiceMMed, Nonin

Saba kugabanyirizwa isoko rya Pulse Oximeter 2018-25 Raporo kuri: https://www.inforgrowth.com/enquiry/r/335427/global-pulse-oximeter-ikimenyetso-ubushakashatsi-amakuru-

Icyifuzo cya FDA kubindi bisobanuro bisabwa hanze kandi yigenga kugeragezwa kwabandi kugirango bahuze amashanyarazi na electrostatike.FDA yasabye kandi amakuru yemeza ubushobozi bwigikoresho cyo gufata ECGs zujuje ubuziranenge bwamavuriro, ugereranije na ECG zanditswemo ukoresheje amashanyarazi asanzwe ya ECG hamwe ninsinga za ECG.CardioComm yahawe iminsi ntarengwa 180 yo gusubiza uwasuzumye FDA.Mugihe Isosiyete yashakaga gusubiza FDA mugihe cyiminsi 90, ibizamini byasabwe hamwe ninyandiko zinyuze mugice cya gatatu ntabwo byemereye igisubizo kuri FDA kurangira muriki gihe.Ibizamini byibikoresho byose byatsinzwe kandi ibisubizo byakusanyirijwe igisubizo kuri FDA.Isaha ya Substantive Isubiramo izongera gutangira FDA imaze kwakira no kwakira igisubizo cyisosiyete.Hashingiwe ku gihe FDA yashyize ahagaragara, Isosiyete ikora ibishoboka byose ngo irangize isuzuma rya 510 (k) mu mpera z'Ukuboza 2018. Isosiyete ivuga ko FDA ifite ubushobozi bwo gusaba igihe kinini cyo kurangiza isuzuma ryabo ku bushake bwa FDA.

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UmutimaCheck ™ CardiBeat ni iyakabiri mubikoresho byinshi byateganijwe byifashishwa na Bluetooth bifashisha amajwi ya ECG kugirango bigurishwe na Sosiyete.Iyambere yari Bluetooth HeartCheck ™ ECG PEN.Nkuko bigaragara mu itangazo ryashyizwe ahagaragara n’isosiyete yo ku ya 22 Gicurasi 2018, porogaramu ya GEMS Smart Smartphone igendanwa izahuza n’ibikoresho byinshi bidafite amajwi ya ECG bifata amajwi, harimo ibyuma 12 bidafite ibyuma byifashisha bizakoreshwa mu buryo butaziguye no gukurikirana abarwayi ba kure ndetse n’isoko rya telemedine.

Rero hejuru yibice bivuguruzanya byinganda za Pulse Oximeter harimo urutonde rwinganda, gahunda, nuburyo bugaragara.Ihanagura kandi ingingo ngenderwaho nkisosiyete ya Pulse Oximeter itumanaho amakuru yerekeye itsinda ryinganda za Pulse Oximeter, ibyiciro, gutondekanya ibipimo, amafaranga yo kugurisha, igiciro / igiciro cyibicuruzwa bya Pulse Oximeter, nabacuruzi bakomeye.

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Porogaramu 510 (k) yatangiye isuzuma ryiminsi 90 Substantive Review na FDA ku ya 8 kamena 2018. FDA yasabye amakuru yinyongera muri Sosiyete yerekeranye nigikoresho cyo ku ya 27 Nyakanga 2018, gihagarika isaha kumurongo wa Substantive Review.Kubara iminsi 90 bizongera gutangira FDA yemera igisubizo cyisosiyete kumakuru yinyongera yasabwe.

Raporo yisoko ryisi yose nububiko bwawe bumwe bwububiko burambuye kandi bwimbitse raporo yubushakashatsi bwakozwe ku isoko bwakozwe nurutonde runini rwabamamaji baturutse kwisi.Dutanga raporo hafi ya domaine zose hamwe nurutonde rwuzuye rwa sub-domaine munsi yizuba.WMR yakozweho ubushakashatsi bwimbitse ikubiyemo domaine ituma abakiriya bacu bahembwa kubyaza umusaruro amahirwe yingenzi yo gukura no gukingira iterabwoba ryizewe ryiganje kumasoko muri iki gihe hamwe nibiteganijwe mugihe cya vuba.

Hariho ibyiciro bishingiye ku bwoko bwibicuruzwa byisoko rya ECG Leadwires.Ibicuruzwa bisaba amakuru yatanzwe nabakoresha kandi raporo ifite amakuru nayo:

Isosiyete izatanga amakuru kuriyi hamwe nigihe kizaza 510 (k).Kugira ngo umenye byinshi kubyerekeye ibicuruzwa bya CardioComm hamwe nibindi bisobanuro bijyanye na HeartCheck ™ ECG ihuza ibikoresho, nyamuneka sura urubuga rwa Sosiyete kuri www.cardiocommsolutions.com na www.umugambi.com.Reba ku Itangazamakuru ryo ku ya 22 Gicurasi 2018 kugira ngo umenye amakuru yerekeye itangwa rya mbere rya FDA.