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FDA 510(k)

AUDIOTONE MODEL A97

K-Number: K920092 · 1992-01-28

ApplicantMiracle-Ear, Inc.
Decision Date1992-01-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUDIOTONE MODEL A97 is the device name listed in this FDA 510(k) record. The listed applicant is Miracle-Ear, Inc.. It received FDA 510(k) clearance on 1992-01-28 under 510(k) number K920092. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIOTONE MODEL A97?

AUDIOTONE MODEL A97 is a medical device that received FDA 510(k) clearance on 1992-01-28. The listed applicant is Miracle-Ear, Inc.. The 510(k) number is K920092.

When did AUDIOTONE MODEL A97 receive FDA 510(k) clearance?

AUDIOTONE MODEL A97 received FDA 510(k) clearance on 1992-01-28, under 510(k) number K920092.

Who is the listed applicant for AUDIOTONE MODEL A97?

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

What is the FDA product code for AUDIOTONE MODEL A97?

The FDA product code for AUDIOTONE MODEL A97 is LYY.

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Other records listing Miracle-Ear, Inc. as applicant

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Related Devices (Code: LYY)

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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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