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FDA 510(k)

GGM Breathing Circuit Bacterial Filter

K-Number: K210352 · 2022-03-27

ApplicantGreat Group Medical Co, Ltd.
Decision Date2022-03-27
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GGM Breathing Circuit Bacterial Filter is the device name listed in this FDA 510(k) record. The listed applicant is Great Group Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-03-27 under 510(k) number K210352. 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 GGM Breathing Circuit Bacterial Filter?

GGM Breathing Circuit Bacterial Filter is a medical device that received FDA 510(k) clearance on 2022-03-27. The listed applicant is Great Group Medical Co, Ltd.. The 510(k) number is K210352.

When did GGM Breathing Circuit Bacterial Filter receive FDA 510(k) clearance?

GGM Breathing Circuit Bacterial Filter received FDA 510(k) clearance on 2022-03-27, under 510(k) number K210352.

Who is the listed applicant for GGM Breathing Circuit Bacterial Filter?

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

What is the FDA product code for GGM Breathing Circuit Bacterial Filter?

The FDA product code for GGM Breathing Circuit Bacterial 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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