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FDA 510(k)

VITAHEAT PATIENT WARMING SYSTEM

K-Number: K132454 · 2013-10-04

ApplicantVitaheat Medical, LLC
Decision Date2013-10-04
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAHEAT PATIENT WARMING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vitaheat Medical, LLC. It received FDA 510(k) clearance on 2013-10-04 under 510(k) number K132454. 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 VITAHEAT PATIENT WARMING SYSTEM?

VITAHEAT PATIENT WARMING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-04. The listed applicant is Vitaheat Medical, LLC. The 510(k) number is K132454.

When did VITAHEAT PATIENT WARMING SYSTEM receive FDA 510(k) clearance?

VITAHEAT PATIENT WARMING SYSTEM received FDA 510(k) clearance on 2013-10-04, under 510(k) number K132454.

Who is the listed applicant for VITAHEAT PATIENT WARMING SYSTEM?

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

What is the FDA product code for VITAHEAT PATIENT WARMING SYSTEM?

The FDA product code for VITAHEAT PATIENT WARMING SYSTEM is DWJ.

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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

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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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