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FDA 510(k)

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT

K-Number: K954828 · 1996-05-02

ApplicantGibeck, Inc.
Decision Date1996-05-02
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT is the device name listed in this FDA 510(k) record. The listed applicant is Gibeck, Inc.. It received FDA 510(k) clearance on 1996-05-02 under 510(k) number K954828. 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 ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT?

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Gibeck, Inc.. The 510(k) number is K954828.

When did ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT receive FDA 510(k) clearance?

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT received FDA 510(k) clearance on 1996-05-02, under 510(k) number K954828.

Who is the listed applicant for ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT?

The FDA 510(k) record lists Gibeck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT?

The FDA product code for ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT is CAH.

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Other records listing Gibeck, Inc. 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.

K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)K964377THERMAL REGULATION SYSTEM BLANKETK964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)K960511GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKETK953491HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLEK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT

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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

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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