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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
Device Name RHYTHMIA MAPPING CATHETER
Applicant
RHYTHMIA MEDICAL, INC
111 SOUTH BEDFORD ST SUITE 205
BURLINGTON,  MA  01803
Applicant Contact LEON AMARIGLIO
Correspondent
RHYTHMIA MEDICAL, INC
111 SOUTH BEDFORD ST SUITE 205
BURLINGTON,  MA  01803
Correspondent Contact LEON AMARIGLIO
Regulation Number870.1220
Classification Product Code
DRF  
Date Received08/13/2012
Decision Date 04/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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