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FDA 510(k)

HUMID-VENT 2

K-Number: K952844 · 1995-07-20

ApplicantGibeck, Inc.
Decision Date1995-07-20
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMID-VENT 2 is the device name listed in this FDA 510(k) record. The listed applicant is Gibeck, Inc.. It received FDA 510(k) clearance on 1995-07-20 under 510(k) number K952844. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMID-VENT 2?

HUMID-VENT 2 is a medical device that received FDA 510(k) clearance on 1995-07-20. The listed applicant is Gibeck, Inc.. The 510(k) number is K952844.

When did HUMID-VENT 2 receive FDA 510(k) clearance?

HUMID-VENT 2 received FDA 510(k) clearance on 1995-07-20, under 510(k) number K952844.

Who is the listed applicant for HUMID-VENT 2?

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 2?

The FDA product code for HUMID-VENT 2 is BYD.

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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 BLANKETK954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORTK953491HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE

View all 15 devices →

Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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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