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FDA 510(k)

HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)

K-Number: K964382 · 1997-04-15

ApplicantGibeck, Inc.
Decision Date1997-04-15
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) is the device name listed in this FDA 510(k) record. The listed applicant is Gibeck, Inc.. It received FDA 510(k) clearance on 1997-04-15 under 510(k) number K964382. 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 HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)?

HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) is a medical device that received FDA 510(k) clearance on 1997-04-15. The listed applicant is Gibeck, Inc.. The 510(k) number is K964382.

When did HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) receive FDA 510(k) clearance?

HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) received FDA 510(k) clearance on 1997-04-15, under 510(k) number K964382.

Who is the listed applicant for HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)?

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 HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)?

The FDA product code for HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) is CAH.

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Other records listing Gibeck, Inc. as applicant

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K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)K964377THERMAL REGULATION SYSTEM BLANKETK960511GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKETK954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORTK953491HUMID-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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