FDA 510(k)

BAG手動復甦器及其附件

K 號：K251631 · 2025-11-24

決定日期2025-11-24

產品代碼BTM

諮詢委員會AN

決定相當於

器材摘要

The BAG manual resuscitator and accessories is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical AS. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K251631. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The BAG manual resuscitator and accessories?

The BAG manual resuscitator and accessories is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Laerdal Medical AS. The 510(k) number is K251631.

When did The BAG manual resuscitator and accessories receive FDA 510(k) clearance?

The BAG manual resuscitator and accessories received FDA 510(k) clearance on 2025-11-24, under 510(k) number K251631.

Who is the listed applicant for The BAG manual resuscitator and accessories?

The FDA 510(k) record lists Laerdal Medical AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The BAG manual resuscitator and accessories?

The FDA product code for The BAG manual resuscitator and accessories is BTM.

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