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FDA 510(k)

BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM

K-Number: K041686 · 2004-06-30

ApplicantArizant Healthcare, Inc.
Decision Date2004-06-30
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arizant Healthcare, Inc.. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K041686. 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 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM?

BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is Arizant Healthcare, Inc.. The 510(k) number is K041686.

When did BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2004-06-30, under 510(k) number K041686.

Who is the listed applicant for BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM?

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

What is the FDA product code for BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM?

The FDA product code for BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM is DWJ.

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Other records listing Arizant Healthcare, 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.

K1204123M SPOTON TEMPERATURE MONITORING SYSTEMK082217RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEMK060939RANGER IRRIGATION FLUID WARMING SYSTEMK060865BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850K053645MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS

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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