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FDA 510(k)

HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)

K-Number: K040440 · 2004-04-27

ApplicantHttp Hypothermia Therapy
Decision Date2004-04-27
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) is the device name listed in this FDA 510(k) record. The listed applicant is Http Hypothermia Therapy. It received FDA 510(k) clearance on 2004-04-27 under 510(k) number K040440. 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 HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)?

HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) is a medical device that received FDA 510(k) clearance on 2004-04-27. The listed applicant is Http Hypothermia Therapy. The 510(k) number is K040440.

When did HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) receive FDA 510(k) clearance?

HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) received FDA 510(k) clearance on 2004-04-27, under 510(k) number K040440.

Who is the listed applicant for HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)?

The FDA 510(k) record lists Http Hypothermia Therapy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)?

The FDA product code for HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) 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

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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