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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hearing aid, group and auditory trainer
510(k) Number K832080
Device Name PHONIC EAR PE 467R-PE 461T
Applicant
PHONIC EAR, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHONIC EAR, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3320
Classification Product Code
EPF  
Date Received06/28/1983
Decision Date 08/01/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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