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FDA 510(k)

BAIR HUGGER CUB BLANKET- SHORT MODEL 536

K-Number: K920432 · 1992-06-18

ApplicantAugustine Medical, Inc.
Decision Date1992-06-18
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAIR HUGGER CUB BLANKET- SHORT MODEL 536 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 1992-06-18 under 510(k) number K920432. 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 CUB BLANKET- SHORT MODEL 536?

BAIR HUGGER CUB BLANKET- SHORT MODEL 536 is a medical device that received FDA 510(k) clearance on 1992-06-18. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K920432.

When did BAIR HUGGER CUB BLANKET- SHORT MODEL 536 receive FDA 510(k) clearance?

BAIR HUGGER CUB BLANKET- SHORT MODEL 536 received FDA 510(k) clearance on 1992-06-18, under 510(k) number K920432.

Who is the listed applicant for BAIR HUGGER CUB BLANKET- SHORT MODEL 536?

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 CUB BLANKET- SHORT MODEL 536?

The FDA product code for BAIR HUGGER CUB BLANKET- SHORT MODEL 536 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 WARMERK964673BAIR HUGGER MODEL 630 CARDIAC BLANKETK963293AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX

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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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