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FDA 510(k)

AMERICAN AIRCARE SYSTEM

K-Number: K811684 · 1981-07-02

ApplicantAmerican Hamilton
Decision Date1981-07-02
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMERICAN AIRCARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Hamilton. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K811684. 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 AMERICAN AIRCARE SYSTEM?

AMERICAN AIRCARE SYSTEM is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is American Hamilton. The 510(k) number is K811684.

When did AMERICAN AIRCARE SYSTEM receive FDA 510(k) clearance?

AMERICAN AIRCARE SYSTEM received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811684.

Who is the listed applicant for AMERICAN AIRCARE SYSTEM?

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

What is the FDA product code for AMERICAN AIRCARE SYSTEM?

The FDA product code for AMERICAN AIRCARE SYSTEM is FNM.

Related Clinical Trials

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Other records listing American Hamilton 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.

K821665PEDESTAL EXAMINING TABLEK810747DISPOSABLE PROBE FOR AQUAMATIC K-THERMIA

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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