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FDA 510(k)

GARD FILTER, COMBIGARD FILTE / HME

K-Number: K014281 · 2002-06-26

ApplicantMunktell Filter AB
Decision Date2002-06-26
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GARD FILTER, COMBIGARD FILTE / HME is the device name listed in this FDA 510(k) record. The listed applicant is Munktell Filter AB. It received FDA 510(k) clearance on 2002-06-26 under 510(k) number K014281. 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 GARD FILTER, COMBIGARD FILTE / HME?

GARD FILTER, COMBIGARD FILTE / HME is a medical device that received FDA 510(k) clearance on 2002-06-26. The listed applicant is Munktell Filter AB. The 510(k) number is K014281.

When did GARD FILTER, COMBIGARD FILTE / HME receive FDA 510(k) clearance?

GARD FILTER, COMBIGARD FILTE / HME received FDA 510(k) clearance on 2002-06-26, under 510(k) number K014281.

Who is the listed applicant for GARD FILTER, COMBIGARD FILTE / HME?

The FDA 510(k) record lists Munktell Filter AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GARD FILTER, COMBIGARD FILTE / HME?

The FDA product code for GARD FILTER, COMBIGARD FILTE / HME is CAH.

Related Clinical Trials

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.

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Other records listing Munktell Filter AB as applicant

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.

K014282BACSTOP FILTER,BACSTOP FILTER/HME

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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