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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 K120941
Device Name CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
Original Applicant
CONSTANT CARE, LLC
1300 i st, nw, 11th floor east
washington,  DC  20005 3314
Original Contact seth a mailhot
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQA   DXN   FLL   FRI   NBW  
NXQ  
Date Received03/29/2012
Decision Date 07/03/2012
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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