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FDA 510(k)

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS

K-Number: K043090 · 2004-12-23

ApplicantPhonic Ear, Inc.
Decision Date2004-12-23
Product CodeLZI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Phonic Ear, Inc.. It received FDA 510(k) clearance on 2004-12-23 under 510(k) number K043090. 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 EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS?

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K043090.

When did EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS receive FDA 510(k) clearance?

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS received FDA 510(k) clearance on 2004-12-23, under 510(k) number K043090.

Who is the listed applicant for EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS?

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

What is the FDA product code for EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS?

The FDA product code for EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS is LZI.

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Other records listing Phonic Ear, Inc. as applicant

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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.

K970974WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPERWilliams Sound, LLCK970340AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIERBellabK954748POCKETALKER PROWilliams Sound, LLCK952057LISTENAIDER 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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