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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K862162
Device Name PHONIC EAR, MODEL PE 1800
Applicant
Phonic Ear, Inc.
250 Camino Alto
Mill Valley,  CA  94941
Applicant Contact ROBERT L REINKE
Correspondent
Phonic Ear, Inc.
250 Camino Alto
Mill Valley,  CA  94941
Correspondent Contact ROBERT L REINKE
Regulation Number874.3310
Classification Product Code
ETW  
Date Received06/06/1986
Decision Date 07/18/1986
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
Predetermined Change
Control Plan Authorized		 No
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