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FDA 510(k)

Breathing circuit bacterial/viral filter

K-Number: K222917 · 2024-02-15

ApplicantShaoxing Haitech Medical Products Co., Ltd.
Decision Date2024-02-15
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: CAH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK241339Besmed Bacterial Filter and HMEFBesmed Health Business CorpK230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , Ltd.K221472Filter and HME/FilterNingbo Huakun Medical Equipment Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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