FDA 510(k)

Strados Remote Electronic Stethoscope Platform (RESP)

Номер K: K220893 · 2022-04-27

Дата решения2022-04-27

Код продуктаDSH

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Strados Remote Electronic Stethoscope Platform (RESP) is the device name listed in this FDA 510(k) record. The listed applicant is Strados Labs, Inc.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220893. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Strados Remote Electronic Stethoscope Platform (RESP)?

Strados Remote Electronic Stethoscope Platform (RESP) is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Strados Labs, Inc.. The 510(k) number is K220893.

When did Strados Remote Electronic Stethoscope Platform (RESP) receive FDA 510(k) clearance?

Strados Remote Electronic Stethoscope Platform (RESP) received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220893.

Who is the listed applicant for Strados Remote Electronic Stethoscope Platform (RESP)?

The FDA 510(k) record lists Strados Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Strados Remote Electronic Stethoscope Platform (RESP)?

The FDA product code for Strados Remote Electronic Stethoscope Platform (RESP) is DSH.

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: DSH)

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

Официальный источник

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