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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 K121480
Model 96281
Device Name ARIATELE TELEMETRY TRANSMITTER (96281)
Original Applicant
SPACELABS HEALTHCARE
p.o. box 3018
nederland,  CO  80466
Original Contact thomas kroenke
Regulation Number870.1025
Classification Product Code
MHX  
Date Received05/18/2012
Decision Date 06/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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