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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 MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Applicant Contact PATRICIA D JONES
Correspondent
SIEMENS MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  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
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