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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K131812
Device Name SENSIS, SENSIS LITE
Applicant
Siemens Medi Cal Solutions, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact PATRICIA D JONES
Correspondent
Siemens Medi Cal Solutions, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact PATRICIA D JONES
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/19/2013
Decision Date 07/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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