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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 K102412
Device Name VISTA DIGITAL OPTHALMOSCOPE
Applicant
EYEQUICK.LLC
1400 COMMON DRIVE
EL PASO,TX,  TX  79936
Applicant Contact MARC ELLMAN MD
Correspondent
EYEQUICK.LLC
1400 COMMON DRIVE
EL PASO,TX,  TX  79936
Correspondent Contact MARC ELLMAN MD
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/24/2010
Decision Date 06/23/2011
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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