FDA 510(k)

鼻部CO2樣品管路，口鼻CO2採樣針管，氧氣口鼻CO2針管，樣品管路

K 號：K151421 · 2016-03-10

決定日期2016-03-10

產品代碼CCK

諮詢委員會AN

決定相當於

器材摘要

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K151421. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines?

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Salter Labs. The 510(k) number is K151421.

When did Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines receive FDA 510(k) clearance?

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines received FDA 510(k) clearance on 2016-03-10, under 510(k) number K151421.

Who is the listed applicant for Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines?

FDA 510(k) 記錄將 Salter Labs 列為申請人。這並不能單獨確立設備製造商。

What is the FDA product code for Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines?

The FDA product code for Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines is CCK.

其他以 Salter Labs 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。

K261389PRO2 Elite Plus 氧氣分析儀 (PRO2PLUS-1)K161719Salter Labs 氣泡濕化器 K151874BiNAPS 鼻腔氣流及鼾聲傳感器；ThermiSense 口腔/鼻腔熱氣流傳感器，配氣流壓力針筒，鼻腔及口腔/鼻腔 K151506需求鼻氧氣管，改良需求鼻氧氣管

相關器械（代碼：CCK）

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。

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官方來源

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