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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 K140450
Device Name KEELER KAPTURE SOFTWARE
Applicant
KEELER LIMITED
456 PARKWAY
BROOMALL,  PA  19008
Applicant Contact EUGENE VAN ARSDALE
Correspondent
KEELER LIMITED
456 PARKWAY
BROOMALL,  PA  19008
Correspondent Contact EUGENE VAN ARSDALE
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/24/2014
Decision Date 06/17/2014
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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