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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, electrode recording, or probe, electrode recording
510(K) Number K122461
Model RM-C00101
Device Name RHYTHMIA MAPPING CATHETER
Applicant
RHYTHMIA MEDICAL, INC
111 south bedford st suite 205
burlington,  MA  01803
Contact leon amariglio
Regulation Number870.1220
Classification Product Code
DRF  
Date Received08/13/2012
Decision Date 04/18/2013
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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