FDA 510(k)

WAVE Clinical Platform

Номер K: K171056 · 2018-01-04

Дата решения2018-01-04

Код продуктаMWI

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

WAVE Clinical Platform is the device name listed in this FDA 510(k) record. The listed applicant is Excel Medical Electronics, LLC. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171056. 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 WAVE Clinical Platform?

WAVE Clinical Platform is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Excel Medical Electronics, LLC. The 510(k) number is K171056.

When did WAVE Clinical Platform receive FDA 510(k) clearance?

WAVE Clinical Platform received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171056.

Who is the listed applicant for WAVE Clinical Platform?

The FDA 510(k) record lists Excel Medical Electronics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVE Clinical Platform?

The FDA product code for WAVE Clinical Platform 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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