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FDA 510(k)

STARKEY SM SERIES BTE HEARING AIDS

K-Number: K923784 · 1992-08-26

ApplicantStarkey Laboratories, Inc.
Decision Date1992-08-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STARKEY SM SERIES BTE HEARING AIDS 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 1992-08-26 under 510(k) number K923784. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARKEY SM SERIES BTE HEARING AIDS?

STARKEY SM SERIES BTE HEARING AIDS is a medical device that received FDA 510(k) clearance on 1992-08-26. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K923784.

When did STARKEY SM SERIES BTE HEARING AIDS receive FDA 510(k) clearance?

STARKEY SM SERIES BTE HEARING AIDS received FDA 510(k) clearance on 1992-08-26, under 510(k) number K923784.

Who is the listed applicant for STARKEY SM SERIES BTE HEARING AIDS?

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 STARKEY SM SERIES BTE HEARING AIDS?

The FDA product code for STARKEY SM SERIES BTE HEARING AIDS is ESD.

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Related Devices (Code: ESD)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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