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FDA 510(k)

SYSTEM, THERMAL REGULATING 74-DWJ

K-Number: K960167 · 1996-06-17

ApplicantAugustine Medical, Inc.
Decision Date1996-06-17
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM, THERMAL REGULATING 74-DWJ 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 1996-06-17 under 510(k) number K960167. 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 SYSTEM, THERMAL REGULATING 74-DWJ?

SYSTEM, THERMAL REGULATING 74-DWJ is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K960167.

When did SYSTEM, THERMAL REGULATING 74-DWJ receive FDA 510(k) clearance?

SYSTEM, THERMAL REGULATING 74-DWJ received FDA 510(k) clearance on 1996-06-17, under 510(k) number K960167.

Who is the listed applicant for SYSTEM, THERMAL REGULATING 74-DWJ?

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 SYSTEM, THERMAL REGULATING 74-DWJ?

The FDA product code for SYSTEM, THERMAL REGULATING 74-DWJ 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.

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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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