FDA 510(k)

WAVE Clinical Platform (2.0.000)

Номер K: K250135 · 2026-01-16

ЗаявительBaxter Healthcare Corp/ Excel Medical

Дата решения2026-01-16

Код продуктаMWI

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

WAVE Clinical Platform (2.0.000) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp/ Excel Medical. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K250135. 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 (2.0.000)?

WAVE Clinical Platform (2.0.000) is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Baxter Healthcare Corp/ Excel Medical. The 510(k) number is K250135.

When did WAVE Clinical Platform (2.0.000) receive FDA 510(k) clearance?

WAVE Clinical Platform (2.0.000) received FDA 510(k) clearance on 2026-01-16, under 510(k) number K250135.

Who is the listed applicant for WAVE Clinical Platform (2.0.000)?

The FDA 510(k) record lists Baxter Healthcare Corp/ Excel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVE Clinical Platform (2.0.000)?

The FDA product code for WAVE Clinical Platform (2.0.000) 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 K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.

Официальный источник

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