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FDA 510(k)

MODEL 90022 ROLLING STAND

K-Number: K963672 · 1997-01-06

ApplicantAugustine Medical, Inc.
Decision Date1997-01-06
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 90022 ROLLING STAND 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 1997-01-06 under 510(k) number K963672. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 90022 ROLLING STAND?

MODEL 90022 ROLLING STAND is a medical device that received FDA 510(k) clearance on 1997-01-06. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K963672.

When did MODEL 90022 ROLLING STAND receive FDA 510(k) clearance?

MODEL 90022 ROLLING STAND received FDA 510(k) clearance on 1997-01-06, under 510(k) number K963672.

Who is the listed applicant for MODEL 90022 ROLLING STAND?

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 MODEL 90022 ROLLING STAND?

The FDA product code for MODEL 90022 ROLLING STAND is JOW.

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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: JOW)

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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