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FDA 510(k)

AUDITORY TRAINER

K-Number: K771671 · 1977-09-12

ApplicantAccutone, Inc.
Decision Date1977-09-12
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDITORY TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Accutone, Inc.. It received FDA 510(k) clearance on 1977-09-12 under 510(k) number K771671. The device is classified under product code EPF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDITORY TRAINER?

AUDITORY TRAINER is a medical device that received FDA 510(k) clearance on 1977-09-12. The listed applicant is Accutone, Inc.. The 510(k) number is K771671.

When did AUDITORY TRAINER receive FDA 510(k) clearance?

AUDITORY TRAINER received FDA 510(k) clearance on 1977-09-12, under 510(k) number K771671.

Who is the listed applicant for AUDITORY TRAINER?

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

What is the FDA product code for AUDITORY TRAINER?

The FDA product code for AUDITORY TRAINER is EPF.

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Related Devices (Code: EPF)

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.

K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONTelex Communications, Inc.K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, ITPhonic Ear, Inc.K974287FM RECEIVER - AUDITORY TRAINERPhonic Ear, Inc.K970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK960567HF MEGA EARMaxi-Aids, 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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