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FDA 510(k)

WILLIAMS SOUND, PERSONAL FM, HEARING HELPER

K-Number: K970665 · 1997-05-02

ApplicantWilliams Sound, LLC
Decision Date1997-05-02
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

WILLIAMS SOUND, PERSONAL FM, HEARING HELPER is the device name listed in this FDA 510(k) record. The listed applicant is Williams Sound, LLC. It received FDA 510(k) clearance on 1997-05-02 under 510(k) number K970665. 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 WILLIAMS SOUND, PERSONAL FM, HEARING HELPER?

WILLIAMS SOUND, PERSONAL FM, HEARING HELPER is a medical device that received FDA 510(k) clearance on 1997-05-02. The listed applicant is Williams Sound, LLC. The 510(k) number is K970665.

When did WILLIAMS SOUND, PERSONAL FM, HEARING HELPER receive FDA 510(k) clearance?

WILLIAMS SOUND, PERSONAL FM, HEARING HELPER received FDA 510(k) clearance on 1997-05-02, under 510(k) number K970665.

Who is the listed applicant for WILLIAMS SOUND, PERSONAL FM, HEARING HELPER?

The FDA 510(k) record lists Williams Sound, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WILLIAMS SOUND, PERSONAL FM, HEARING HELPER?

The FDA product code for WILLIAMS SOUND, PERSONAL FM, HEARING HELPER is EPF.

Related Clinical Trials

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.

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Other records listing Williams Sound, LLC 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.

K970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERK970974WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPERK954748POCKETALKER PRO

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, LLCK960567HF MEGA EARMaxi-Aids, Inc.K950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)Phonic Ear, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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