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FDA 510(k)

BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540

K-Number: K921165 · 1992-08-06

ApplicantAugustine Medical, Inc.
Decision Date1992-08-06
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 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 1992-08-06 under 510(k) number K921165. 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 TORSO BLANKET - ARMS IN MODEL 540?

BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 is a medical device that received FDA 510(k) clearance on 1992-08-06. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K921165.

When did BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 receive FDA 510(k) clearance?

BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 received FDA 510(k) clearance on 1992-08-06, under 510(k) number K921165.

Who is the listed applicant for BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540?

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 TORSO BLANKET - ARMS IN MODEL 540?

The FDA product code for BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 is DWJ.

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Other records listing Augustine Medical, Inc. as applicant

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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)

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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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