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FDA 510(k)

THE AIRCEL SYSTEM

K-Number: K954593 · 1996-02-06

ApplicantMarcon Group, Inc.
Decision Date1996-02-06
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE AIRCEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Marcon Group, Inc.. It received FDA 510(k) clearance on 1996-02-06 under 510(k) number K954593. 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 THE AIRCEL SYSTEM?

THE AIRCEL SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Marcon Group, Inc.. The 510(k) number is K954593.

When did THE AIRCEL SYSTEM receive FDA 510(k) clearance?

THE AIRCEL SYSTEM received FDA 510(k) clearance on 1996-02-06, under 510(k) number K954593.

Who is the listed applicant for THE AIRCEL SYSTEM?

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

What is the FDA product code for THE AIRCEL SYSTEM?

The FDA product code for THE AIRCEL 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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