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FDA 510(k)

BACSTOP FILTER,BACSTOP FILTER/HME

K-Number: K014282 · 2002-06-26

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

Device Summary

BACSTOP FILTER,BACSTOP FILTER/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 K014282. 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 BACSTOP FILTER,BACSTOP FILTER/HME?

BACSTOP FILTER,BACSTOP FILTER/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 K014282.

When did BACSTOP FILTER,BACSTOP FILTER/HME receive FDA 510(k) clearance?

BACSTOP FILTER,BACSTOP FILTER/HME received FDA 510(k) clearance on 2002-06-26, under 510(k) number K014282.

Who is the listed applicant for BACSTOP FILTER,BACSTOP FILTER/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 BACSTOP FILTER,BACSTOP FILTER/HME?

The FDA product code for BACSTOP FILTER,BACSTOP FILTER/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.

K014281GARD FILTER, COMBIGARD FILTE / 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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