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FDA 510(k)

MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000

K-Number: K071341 · 2007-08-03

ApplicantMedivance, Inc.
Decision Date2007-08-03
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Medivance, Inc.. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K071341. 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 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000?

MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Medivance, Inc.. The 510(k) number is K071341.

When did MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 receive FDA 510(k) clearance?

MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 received FDA 510(k) clearance on 2007-08-03, under 510(k) number K071341.

Who is the listed applicant for MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000?

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

What is the FDA product code for MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000?

The FDA product code for MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 is DWJ.

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Other records listing Medivance, Inc. as applicant

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Related Devices (Code: DWJ)

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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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