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FDA 510(k)

MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002

K-Number: K083135 · 2008-10-31

ApplicantThermogear, Inc.
Decision Date2008-10-31
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 is the device name listed in this FDA 510(k) record. The listed applicant is Thermogear, Inc.. It received FDA 510(k) clearance on 2008-10-31 under 510(k) number K083135. 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 MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002?

MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 is a medical device that received FDA 510(k) clearance on 2008-10-31. The listed applicant is Thermogear, Inc.. The 510(k) number is K083135.

When did MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 receive FDA 510(k) clearance?

MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 received FDA 510(k) clearance on 2008-10-31, under 510(k) number K083135.

Who is the listed applicant for MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002?

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

What is the FDA product code for MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002?

The FDA product code for MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 is DWJ.

Related Clinical Trials

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Other records listing Thermogear, 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.

K071918CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002K991684CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001

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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