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FDA 510(k)

AIR-MEDEX I

K-Number: K961769 · 1996-10-08

ApplicantRobert Gold Assoc.
Decision Date1996-10-08
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIR-MEDEX I is the device name listed in this FDA 510(k) record. The listed applicant is Robert Gold Assoc.. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K961769. 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 AIR-MEDEX I?

AIR-MEDEX I is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Robert Gold Assoc.. The 510(k) number is K961769.

When did AIR-MEDEX I receive FDA 510(k) clearance?

AIR-MEDEX I received FDA 510(k) clearance on 1996-10-08, under 510(k) number K961769.

Who is the listed applicant for AIR-MEDEX I?

The FDA 510(k) record lists Robert Gold Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR-MEDEX I?

The FDA product code for AIR-MEDEX I 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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