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FDA 510(k)

AIR MATTRESS

K-Number: K813407 · 1981-12-31

ApplicantTrans World Agency, Inc.
Decision Date1981-12-31
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIR MATTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Trans World Agency, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813407. 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 MATTRESS?

AIR MATTRESS is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Trans World Agency, Inc.. The 510(k) number is K813407.

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

AIR MATTRESS received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813407.

Who is the listed applicant for AIR MATTRESS?

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

What is the FDA product code for AIR MATTRESS?

The FDA product code for AIR 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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Other records listing Trans World Agency, 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.

K812176KORICLEAN

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.K974319MIGHTY AIRWheelchairs of KansasK972022ZAK-2000Cardio Systems, Inc.K974070PHYSIO/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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