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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 K152308
Device Name Sensor Medical Single Use Tonometer Prism
Applicant
Sensor Medical Technology, LLC
23175 224th Pl. SE
Maple Valley,  WA  98038
Applicant Contact Louise Culham
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number886.1930
Classification Product Code
HKY  
Date Received08/14/2015
Decision Date 10/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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