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FDA 510(k)

POCKETALKER PRO

K-Number: K954748 · 1995-11-22

ApplicantWilliams Sound, LLC
Decision Date1995-11-22
Product CodeLZI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POCKETALKER PRO 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 1995-11-22 under 510(k) number K954748. The device is classified under product code LZI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POCKETALKER PRO?

POCKETALKER PRO is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is Williams Sound, LLC. The 510(k) number is K954748.

When did POCKETALKER PRO receive FDA 510(k) clearance?

POCKETALKER PRO received FDA 510(k) clearance on 1995-11-22, under 510(k) number K954748.

Who is the listed applicant for POCKETALKER PRO?

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 POCKETALKER PRO?

The FDA product code for POCKETALKER PRO is LZI.

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.

K970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERK970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERK970974WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER

Related Devices (Code: LZI)

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.

K043090EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSPhonic Ear, Inc.K970974WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPERWilliams Sound, LLCK970340AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIERBellabK952057LISTENAIDER IINational Hearing Aid Dist., Inc.K934805HEARITJe Liss & Co., Inc.K904755ACOUSTIQ LISTENING DEVICEKrueger Laboratories

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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