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FDA 510(k)

0184 CO2 標本採集管;0184T CO2 標本採集管;0139 CO2 標本採集管;0182 CO2 標本採集管

K 號:K251216 · 2025-06-04

決定日期2025-06-04
產品代碼CCK
諮詢委員會AN
決定相當於

器材摘要

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line is the device name listed in this FDA 510(k) record. The listed applicant is Barbaras Development, Inc.. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K251216. 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 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line?

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Barbaras Development, Inc.. The 510(k) number is K251216.

When did 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line receive FDA 510(k) clearance?

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line received FDA 510(k) clearance on 2025-06-04, under 510(k) number K251216.

Who is the listed applicant for 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line?

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

What is the FDA product code for 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line?

The FDA product code for 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line is CCK.

相關臨床試驗

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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。

官方來源

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