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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 K913118
Device Name GLAUCOMA-SCOPE
Applicant
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Applicant Contact STEVEN R VERDOONER
Correspondent
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Correspondent Contact STEVEN R VERDOONER
Regulation Number886.1570
Classification Product Code
HLI  
Date Received07/15/1991
Decision Date 10/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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