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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K141156
Device Name SPACELABS HEALTHCARE TELEMETRY RECEIVER
Applicant
Spacelabs Healthcare
P.O. Box 3018
Nederland,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
Spacelabs Healthcare
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSI   MLD   MSX  
Date Received05/05/2014
Decision Date 09/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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