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FDA 510(k)

GROUP AUDITORY TRAINER,FM RECEIVER

K-Number: K912356 · 1991-08-15

ApplicantPhonic Ear, Inc.
Decision Date1991-08-15
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GROUP AUDITORY TRAINER,FM RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Phonic Ear, Inc.. It received FDA 510(k) clearance on 1991-08-15 under 510(k) number K912356. 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 GROUP AUDITORY TRAINER,FM RECEIVER?

GROUP AUDITORY TRAINER,FM RECEIVER is a medical device that received FDA 510(k) clearance on 1991-08-15. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K912356.

When did GROUP AUDITORY TRAINER,FM RECEIVER receive FDA 510(k) clearance?

GROUP AUDITORY TRAINER,FM RECEIVER received FDA 510(k) clearance on 1991-08-15, under 510(k) number K912356.

Who is the listed applicant for GROUP AUDITORY TRAINER,FM RECEIVER?

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

What is the FDA product code for GROUP AUDITORY TRAINER,FM RECEIVER?

The FDA product code for GROUP AUDITORY TRAINER,FM RECEIVER is EPF.

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Other records listing Phonic Ear, 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.

K043090EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSK974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, ITK974287FM RECEIVER - AUDITORY TRAINERK950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)K940313PHONIC EARK923234PE 400IR, PE 400T, PE 400E

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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

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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