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FDA 510(k)

Filter and HME/Filter

K-Number: K221472 · 2023-02-08

ApplicantNingbo Huakun Medical Equipment Co., Ltd.
Decision Date2023-02-08
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Filter and HME/Filter is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Huakun Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K221472. 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 Filter and HME/Filter?

Filter and HME/Filter is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Ningbo Huakun Medical Equipment Co., Ltd.. The 510(k) number is K221472.

When did Filter and HME/Filter receive FDA 510(k) clearance?

Filter and HME/Filter received FDA 510(k) clearance on 2023-02-08, under 510(k) number K221472.

Who is the listed applicant for Filter and HME/Filter?

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

What is the FDA product code for Filter and HME/Filter?

The FDA product code for Filter and HME/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 CorpK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , Ltd.

Official Source

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

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