FDA 510(k)

一氧化碳呼吸感測系統（COBSS）

K 號：K171408 · 2017-09-29

決定日期2017-09-29

產品代碼CCJ

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：CCJ）

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K253119CoSense ETCO 監護儀Capnia, Inc.K211918iCOquit® 烟霧測試儀®Bedfont Scientific, Ltd.K201206Pivot 呼吸感測器Carrot, Inc.K173238毒碳Bedfont Scientific, Ltd.K171129CO Check Pro, 一氧化碳檢測器 CO Screen, 一氧化碳檢測屏MD Diagnostics Limited

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：CCJ）

官方來源