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FDA 510(k)

UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX

K-Number: K093244 · 2010-10-19

ApplicantGeratherm Medical AG
Decision Date2010-10-19
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX is the device name listed in this FDA 510(k) record. The listed applicant is Geratherm Medical AG. It received FDA 510(k) clearance on 2010-10-19 under 510(k) number K093244. 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 UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX?

UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX is a medical device that received FDA 510(k) clearance on 2010-10-19. The listed applicant is Geratherm Medical AG. The 510(k) number is K093244.

When did UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX receive FDA 510(k) clearance?

UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX received FDA 510(k) clearance on 2010-10-19, under 510(k) number K093244.

Who is the listed applicant for UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX?

The FDA 510(k) record lists Geratherm Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX?

The FDA product code for UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX is DWJ.

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Other records listing Geratherm Medical AG 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.

K093694GERATHERM UNIQUERESC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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