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FDA 510(k)

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

K-Number: K965016 · 1997-12-02

ApplicantGibeck, Inc.
Decision Date1997-12-02
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) is the device name listed in this FDA 510(k) record. The listed applicant is Gibeck, Inc.. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K965016. 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 FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)?

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Gibeck, Inc.. The 510(k) number is K965016.

When did ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) receive FDA 510(k) clearance?

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) received FDA 510(k) clearance on 1997-12-02, under 510(k) number K965016.

Who is the listed applicant for ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)?

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 FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)?

The FDA product code for ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) is CAH.

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Other records listing Gibeck, Inc. as applicant

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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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