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FDA 510(k)

MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS

K-Number: K053645 · 2006-03-09

ApplicantArizant Healthcare, Inc.
Decision Date2006-03-09
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS 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 2006-03-09 under 510(k) number K053645. 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:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS?

MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS is a medical device that received FDA 510(k) clearance on 2006-03-09. The listed applicant is Arizant Healthcare, Inc.. The 510(k) number is K053645.

When did MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS receive FDA 510(k) clearance?

MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS received FDA 510(k) clearance on 2006-03-09, under 510(k) number K053645.

Who is the listed applicant for MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS?

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 MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS?

The FDA product code for MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS 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 850K041686BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM

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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