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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K142179
Device Name D-KAT Z-YPE
Applicant
Keeler, Ltd.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact EUGENE R VAN ARSDALE
Correspondent
Keeler, Ltd.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact EUGENE R VAN ARSDALE
Regulation Number886.1930
Classification Product Code
HKY  
Date Received08/08/2014
Decision Date 09/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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