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FDA 510(k)

FM RECEIVER - AUDITORY TRAINER

K-Number: K974287 · 1998-02-10

ApplicantPhonic Ear, Inc.
Decision Date1998-02-10
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FM RECEIVER - AUDITORY TRAINER 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 1998-02-10 under 510(k) number K974287. 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 FM RECEIVER - AUDITORY TRAINER?

FM RECEIVER - AUDITORY TRAINER is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K974287.

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

FM RECEIVER - AUDITORY TRAINER received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974287.

Who is the listed applicant for FM RECEIVER - AUDITORY TRAINER?

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 FM RECEIVER - AUDITORY TRAINER?

The FDA product code for FM RECEIVER - AUDITORY TRAINER 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, ITK950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)K940313PHONIC EARK923234PE 400IR, PE 400T, PE 400EK922720GROUP AUDITORY TRAINING SYSTEM

View all 31 devices →

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.K970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK960567HF MEGA EARMaxi-Aids, Inc.K950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)Phonic Ear, 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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