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FDA 510(k)

TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION

K-Number: K982683 · 1998-10-06

ApplicantTelex Communications, Inc.
Decision Date1998-10-06
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION 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 1998-10-06 under 510(k) number K982683. 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 TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION?

TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION is a medical device that received FDA 510(k) clearance on 1998-10-06. The listed applicant is Telex Communications, Inc.. The 510(k) number is K982683.

When did TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION receive FDA 510(k) clearance?

TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION received FDA 510(k) clearance on 1998-10-06, under 510(k) number K982683.

Who is the listed applicant for TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION?

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 TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION?

The FDA product code for TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION 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-COMPANIONK964639TELEX 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 COMPRESSIONK943961THE MODEL ACAPPELLA IN THE EAR HEARING AID

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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.

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.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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