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FDA 510(k)

TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER

K-Number: K915398 · 1992-01-17

ApplicantTelex Communications, Inc.
Decision Date1992-01-17
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Telex Communications, Inc.. It received FDA 510(k) clearance on 1992-01-17 under 510(k) number K915398. 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 TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER?

TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER is a medical device that received FDA 510(k) clearance on 1992-01-17. The listed applicant is Telex Communications, Inc.. The 510(k) number is K915398.

When did TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER receive FDA 510(k) clearance?

TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER received FDA 510(k) clearance on 1992-01-17, under 510(k) number K915398.

Who is the listed applicant for TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER?

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

What is the FDA product code for TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER?

The FDA product code for TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER is EPF.

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Other records listing Telex Communications, 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.

K984243TELEX TINNITUS-COMPANIONK982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONK964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-IIK963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONK961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION

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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.K970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970687WILLIAMS 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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