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FDA 510(k)

BAIR HUGGER MODEL 630 CARDIAC BLANKET

K-Number: K964673 · 1997-06-26

ApplicantAugustine Medical, Inc.
Decision Date1997-06-26
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAIR HUGGER MODEL 630 CARDIAC BLANKET is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Medical, Inc.. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K964673. 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 MODEL 630 CARDIAC BLANKET?

BAIR HUGGER MODEL 630 CARDIAC BLANKET is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K964673.

When did BAIR HUGGER MODEL 630 CARDIAC BLANKET receive FDA 510(k) clearance?

BAIR HUGGER MODEL 630 CARDIAC BLANKET received FDA 510(k) clearance on 1997-06-26, under 510(k) number K964673.

Who is the listed applicant for BAIR HUGGER MODEL 630 CARDIAC BLANKET?

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

What is the FDA product code for BAIR HUGGER MODEL 630 CARDIAC BLANKET?

The FDA product code for BAIR HUGGER MODEL 630 CARDIAC BLANKET is DWJ.

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Other records listing Augustine Medical, 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.

K021473BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMK020077MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXXK001149AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANKK973741BAIR HUGGER BLOOD/FLUID WARMERK963293AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXXK963672MODEL 90022 ROLLING STAND

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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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