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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K953972
Device Name ANGIOVISION VIEWING STATION
Applicant
Medivision Medical Imaging, Ltd.
The Manor House
Two Hayden Rowe
Hopkinton,  MA  01748
Applicant Contact RICHARD A DOMAIGUE
Correspondent
Medivision Medical Imaging, Ltd.
The Manor House
Two Hayden Rowe
Hopkinton,  MA  01748
Correspondent Contact RICHARD A DOMAIGUE
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/23/1995
Decision Date 11/17/1995
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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