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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, assistive listening
510(k) Number K043090
Device Name EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
Applicant
PHONIC EAR, INC.
3880 CYPRESS DR.
PETALUMA,  CA  94954 -7600
Applicant Contact TODD BISSEY
Correspondent
PHONIC EAR, INC.
3880 CYPRESS DR.
PETALUMA,  CA  94954 -7600
Correspondent Contact TODD BISSEY
Regulation Number874.3320
Classification Product Code
LZI  
Date Received11/08/2004
Decision Date 12/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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