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FDA 510(k)

TELEX TINNITUS-COMPANION

K-Number: K984243 · 1999-01-21

ApplicantTelex Communications, Inc.
Decision Date1999-01-21
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELEX TINNITUS-COMPANION 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 1999-01-21 under 510(k) number K984243. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELEX TINNITUS-COMPANION?

TELEX TINNITUS-COMPANION is a medical device that received FDA 510(k) clearance on 1999-01-21. The listed applicant is Telex Communications, Inc.. The 510(k) number is K984243.

When did TELEX TINNITUS-COMPANION receive FDA 510(k) clearance?

TELEX TINNITUS-COMPANION received FDA 510(k) clearance on 1999-01-21, under 510(k) number K984243.

Who is the listed applicant for TELEX TINNITUS-COMPANION?

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 TINNITUS-COMPANION?

The FDA product code for TELEX TINNITUS-COMPANION is KLW.

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Other records listing Telex Communications, Inc. as applicant

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K982683TELEX 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 COMPRESSIONK943961THE MODEL ACAPPELLA IN THE EAR HEARING AID

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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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