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FDA 510(k)

BAIR HUGGER BLOOD/FLUID WARMER

K-Number: K973741 · 1998-04-30

ApplicantAugustine Medical, Inc.
Decision Date1998-04-30
Product CodeBSB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BAIR HUGGER BLOOD/FLUID WARMER 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 1998-04-30 under 510(k) number K973741. The device is classified under product code BSB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAIR HUGGER BLOOD/FLUID WARMER?

BAIR HUGGER BLOOD/FLUID WARMER is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K973741.

When did BAIR HUGGER BLOOD/FLUID WARMER receive FDA 510(k) clearance?

BAIR HUGGER BLOOD/FLUID WARMER received FDA 510(k) clearance on 1998-04-30, under 510(k) number K973741.

Who is the listed applicant for BAIR HUGGER BLOOD/FLUID WARMER?

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 BLOOD/FLUID WARMER?

The FDA product code for BAIR HUGGER BLOOD/FLUID WARMER is BSB.

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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 BLANKK964673BAIR HUGGER MODEL 630 CARDIAC BLANKETK963293AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXXK963672MODEL 90022 ROLLING STAND

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Related Devices (Code: BSB)

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.

K112639THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.K090508THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.K062774BELMONT BUDDY PLUS FLUID WARMERBelmont Instrument Corp.K052547BELMONT BUDDY FLUID WARMERBelmont Instrument Corp.K031478MICROHEATERBelmont Instrument Corp.K020060ASTOFLONats Corp.

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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