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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 K092374
Device Name OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
Applicant
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Applicant Contact ANDREA AMBROSE
Correspondent
OPHTHALMIC IMAGING SYSTEMS
221 LATHROP WAY, SUITE I
SACRAMENTO,  CA  95815
Correspondent Contact ANDREA AMBROSE
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Codes
HJO   NFG  
Date Received08/05/2009
Decision Date 11/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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