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FDA 510(k)

THERMAL REGULATION SYSTEM BLANKET

K-Number: K964377 · 1997-04-23

ApplicantGibeck, Inc.
Decision Date1997-04-23
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMAL REGULATION SYSTEM BLANKET is the device name listed in this FDA 510(k) record. The listed applicant is Gibeck, Inc.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K964377. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAL REGULATION SYSTEM BLANKET?

THERMAL REGULATION SYSTEM BLANKET is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Gibeck, Inc.. The 510(k) number is K964377.

When did THERMAL REGULATION SYSTEM BLANKET receive FDA 510(k) clearance?

THERMAL REGULATION SYSTEM BLANKET received FDA 510(k) clearance on 1997-04-23, under 510(k) number K964377.

Who is the listed applicant for THERMAL REGULATION SYSTEM BLANKET?

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 THERMAL REGULATION SYSTEM BLANKET?

The FDA product code for THERMAL REGULATION SYSTEM BLANKET is DWJ.

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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)K964382HUMID-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 ANGLEK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT

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Related Devices (Code: DWJ)

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, 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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