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FDA 510(k)

ALTERNATING PRESSURE AIR FLOTATION MATTRESS

K-Number: K972153 · 1997-07-31

ApplicantDecubiti Concepts, Inc.
Decision Date1997-07-31
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALTERNATING PRESSURE AIR FLOTATION MATTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Decubiti Concepts, Inc.. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K972153. 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 ALTERNATING PRESSURE AIR FLOTATION MATTRESS?

ALTERNATING PRESSURE AIR FLOTATION MATTRESS is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Decubiti Concepts, Inc.. The 510(k) number is K972153.

When did ALTERNATING PRESSURE AIR FLOTATION MATTRESS receive FDA 510(k) clearance?

ALTERNATING PRESSURE AIR FLOTATION MATTRESS received FDA 510(k) clearance on 1997-07-31, under 510(k) number K972153.

Who is the listed applicant for ALTERNATING PRESSURE AIR FLOTATION MATTRESS?

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

What is the FDA product code for ALTERNATING PRESSURE AIR FLOTATION MATTRESS?

The FDA product code for ALTERNATING PRESSURE AIR FLOTATION MATTRESS is FNM.

Related Clinical Trials

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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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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