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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 K191331
Device Name Life Sensor Cardiac Monitor
Applicant
Braveheart Wireless, Inc.
11 Perimeter Rd.
Nashua,  NH  03063
Applicant Contact Balaji Sudabattula
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DRT   DRX  
Date Received05/16/2019
Decision Date 06/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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