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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 K152881
Device Name SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
Applicant
SPACELABS HEALTHCARE LTD.
1 HARFORDE COURT
JOHN TATE ROAD
HERTFORD,  GB SG13 7NW
Applicant Contact AL VAN HOUDT
Correspondent
SPEED TO MARKET,INC.
PO BOX 3018
NEDERLAND,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DXH  
Date Received09/30/2015
Decision Date 04/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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