FDA 510(k)

Breathing circuit bacterial/viral filter

Numéro K : K222917 · 2024-02-15

DemandeurShaoxing Haitech Medical Products Co., Ltd.

Date de décision2024-02-15

Code produitCAH

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Breathing circuit bacterial/viral filter is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Haitech Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K222917. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Breathing circuit bacterial/viral filter?

Breathing circuit bacterial/viral filter is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Shaoxing Haitech Medical Products Co., Ltd.. The 510(k) number is K222917.

When did Breathing circuit bacterial/viral filter receive FDA 510(k) clearance?

Breathing circuit bacterial/viral filter received FDA 510(k) clearance on 2024-02-15, under 510(k) number K222917.

Who is the listed applicant for Breathing circuit bacterial/viral filter?

The FDA 510(k) record lists Shaoxing Haitech Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breathing circuit bacterial/viral filter?

The FDA product code for Breathing circuit bacterial/viral filter is CAH.

Essais cliniques associés

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Dispositifs connexes (Code : CAH)

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Source officielle

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