FDA 510(k)

BETTERCARE PLATFORM - ADVANCED WEB CLIENT

Номер K: K171361 · 2018-02-05

Дата решения2018-02-05

Код продуктаMWI

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

BETTERCARE PLATFORM - ADVANCED WEB CLIENT is the device name listed in this FDA 510(k) record. The listed applicant is Better Care S.L.. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K171361. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the BETTERCARE PLATFORM - ADVANCED WEB CLIENT?

BETTERCARE PLATFORM - ADVANCED WEB CLIENT is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is Better Care S.L.. The 510(k) number is K171361.

When did BETTERCARE PLATFORM - ADVANCED WEB CLIENT receive FDA 510(k) clearance?

BETTERCARE PLATFORM - ADVANCED WEB CLIENT received FDA 510(k) clearance on 2018-02-05, under 510(k) number K171361.

Who is the listed applicant for BETTERCARE PLATFORM - ADVANCED WEB CLIENT?

The FDA 510(k) record lists Better Care S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BETTERCARE PLATFORM - ADVANCED WEB CLIENT?

The FDA product code for BETTERCARE PLATFORM - ADVANCED WEB CLIENT is MWI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Официальный источник

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