FDA 510(k)

Carbon Monoxide Breath Sensor System (COBSS)

Номер K: K171408 · 2017-09-29

Дата решения2017-09-29

Код продуктаCCJ

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

Carbon Monoxide Breath Sensor System (COBSS) is the device name listed in this FDA 510(k) record. The listed applicant is Carrot Sense, Inc.. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K171408. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Carbon Monoxide Breath Sensor System (COBSS)?

Carbon Monoxide Breath Sensor System (COBSS) is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Carrot Sense, Inc.. The 510(k) number is K171408.

When did Carbon Monoxide Breath Sensor System (COBSS) receive FDA 510(k) clearance?

Carbon Monoxide Breath Sensor System (COBSS) received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171408.

Who is the listed applicant for Carbon Monoxide Breath Sensor System (COBSS)?

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

What is the FDA product code for Carbon Monoxide Breath Sensor System (COBSS)?

The FDA product code for Carbon Monoxide Breath Sensor System (COBSS) is CCJ.

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: CCJ)

K253119CoSense ETCO MonitorCapnia, Inc.K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd.K201206Pivot Breath SensorCarrot, Inc.K173238ToxCOBedfont Scientific, Ltd.K171129CO Check Pro, CO ScreenMD Diagnostics Limited

Официальный источник

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