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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(K) Number K122333
Model RELEASE 4
Device Name MOBILECARE MONITOR
Applicant
AFRAME DIGITAL, INC.
1889 preston white drive
suite 101
reston,  VA  20191
Contact jill thorpe
Regulation Number870.2910
Classification Product Code
DRG  
Date Received08/02/2012
Decision Date 11/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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