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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K130750
Device Name RHYTHMIA MAPPING SYSTEM
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 Number870.1425
Classification Product Code
DQK  
Date Received03/19/2013
Decision Date 07/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01642537
Reviewed by Third Party No
Combination Product No
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