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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K912397
Device Name PROFESSIONAL INDIRECT OPHTHALMOSCOPE
Applicant
Clement Clarke, Inc.
Airmed House, Edinburgh Way
Harlow, Essex Cm20 2ed
England,  GB
Applicant Contact MICHAEL J WILKINSON
Correspondent
Clement Clarke, Inc.
Airmed House, Edinburgh Way
Harlow, Essex Cm20 2ed
England,  GB
Correspondent Contact MICHAEL J WILKINSON
Regulation Number886.1570
Classification Product Code
HLI  
Date Received05/28/1991
Decision Date 10/23/1991
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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