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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retinoscope, Ac-Powered
510(k) Number K001111
Device Name PANORET, MODEL 1000A
Applicant
Cmt Medical Technologies, Ltd.
Matam High Technology Center
Haifa,  IL 31905
Applicant Contact ILAN SHARON
Correspondent
Cmt Medical Technologies, Ltd.
Matam High Technology Center
Haifa,  IL 31905
Correspondent Contact ILAN SHARON
Regulation Number886.1780
Classification Product Code
HKL  
Date Received04/06/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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