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FDA 510(k)

HEARING AID, MODEL MA-1

K-Number: K791142 · 1979-09-28

Decision Date1979-09-28
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID, MODEL MA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 1979-09-28 under 510(k) number K791142. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARING AID, MODEL MA-1?

HEARING AID, MODEL MA-1 is a medical device that received FDA 510(k) clearance on 1979-09-28. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K791142.

When did HEARING AID, MODEL MA-1 receive FDA 510(k) clearance?

HEARING AID, MODEL MA-1 received FDA 510(k) clearance on 1979-09-28, under 510(k) number K791142.

Who is the listed applicant for HEARING AID, MODEL MA-1?

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

What is the FDA product code for HEARING AID, MODEL MA-1?

The FDA product code for HEARING AID, MODEL MA-1 is KLW.

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.

Other records listing Starkey Laboratories, 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.

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Related Devices (Code: KLW)

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.

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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