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FDA 510(k)

UNIT-MATT 5000 PRESSURE RELIEF SYSTEM

K-Number: K962585 · 1997-01-07

ApplicantUnited Medical Equipment, Inc.
Decision Date1997-01-07
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNIT-MATT 5000 PRESSURE RELIEF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United Medical Equipment, Inc.. It received FDA 510(k) clearance on 1997-01-07 under 510(k) number K962585. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIT-MATT 5000 PRESSURE RELIEF SYSTEM?

UNIT-MATT 5000 PRESSURE RELIEF SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-07. The listed applicant is United Medical Equipment, Inc.. The 510(k) number is K962585.

When did UNIT-MATT 5000 PRESSURE RELIEF SYSTEM receive FDA 510(k) clearance?

UNIT-MATT 5000 PRESSURE RELIEF SYSTEM received FDA 510(k) clearance on 1997-01-07, under 510(k) number K962585.

Who is the listed applicant for UNIT-MATT 5000 PRESSURE RELIEF SYSTEM?

The FDA 510(k) record lists United Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIT-MATT 5000 PRESSURE RELIEF SYSTEM?

The FDA product code for UNIT-MATT 5000 PRESSURE RELIEF SYSTEM is FNM.

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Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.

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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