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FDA 510(k)

MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM

K-Number: K933726 · 1994-01-28

ApplicantAugustine Medical, Inc.
Decision Date1994-01-28
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM 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 1994-01-28 under 510(k) number K933726. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM?

MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K933726.

When did MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM receive FDA 510(k) clearance?

MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM received FDA 510(k) clearance on 1994-01-28, under 510(k) number K933726.

Who is the listed applicant for MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM?

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 MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM?

The FDA product code for MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM is LHC.

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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: LHC)

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.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLCK152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLCK080609SWC/DWC WARMING CABINETSMac MedicalK051819C CHANGE SOLUTION WARMERC Change Surgical, LLCK0232831075LD HUSH-SLUSHO.R. Solutions, 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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