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FDA 510(k)

GROUP AUDITORY TRAINER HC 431R

K-Number: K771357 · 1977-07-29

ApplicantHc Electronics
Decision Date1977-07-29
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GROUP AUDITORY TRAINER HC 431R is the device name listed in this FDA 510(k) record. The listed applicant is Hc Electronics. It received FDA 510(k) clearance on 1977-07-29 under 510(k) number K771357. 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 HC 431R?

GROUP AUDITORY TRAINER HC 431R is a medical device that received FDA 510(k) clearance on 1977-07-29. The listed applicant is Hc Electronics. The 510(k) number is K771357.

When did GROUP AUDITORY TRAINER HC 431R receive FDA 510(k) clearance?

GROUP AUDITORY TRAINER HC 431R received FDA 510(k) clearance on 1977-07-29, under 510(k) number K771357.

Who is the listed applicant for GROUP AUDITORY TRAINER HC 431R?

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

What is the FDA product code for GROUP AUDITORY TRAINER HC 431R?

The FDA product code for GROUP AUDITORY TRAINER HC 431R is EPF.

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Other records listing Hc Electronics 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.

K810031STEREO AUDITORY TRAINER (MODEL PM228)K810030POST-AURICULAR HEARING AID (#PE830)K800340PHONIC EAR, MODEL 841LK782053HEARING AID, POST-AURICULARK780936PHONIC EARK780363PHONIC EAR

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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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