FDA 510(k)

毒碳

K 號：K173238 · 2019-04-04

決定日期2019-04-04

產品代碼CCJ

諮詢委員會AN

決定相當於

器材摘要

ToxCO is the device name listed in this FDA 510(k) record. The listed applicant is Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K173238. 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 ToxCO?

ToxCO is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Bedfont Scientific, Ltd.. The 510(k) number is K173238.

When did ToxCO receive FDA 510(k) clearance?

ToxCO received FDA 510(k) clearance on 2019-04-04, under 510(k) number K173238.

Who is the listed applicant for ToxCO?

The FDA 510(k) record lists Bedfont Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ToxCO?

The FDA product code for ToxCO is CCJ.

其他以 Bedfont Scientific, Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K211918iCOquit® 烟霧測試儀®K203695NObreath®

相關器械（代碼：CCJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253119CoSense ETCO 監護儀Capnia, Inc.K211918iCOquit® 烟霧測試儀®Bedfont Scientific, Ltd.K201206Pivot 呼吸感測器Carrot, Inc.K171129CO Check Pro, 一氧化碳檢測器 CO Screen, 一氧化碳檢測屏MD Diagnostics Limited K171408一氧化碳呼吸感測系統（COBSS）Carrot Sense, Inc.

官方來源

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