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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 K173510
Device Name BioStamp nPoint
Applicant
MC10 Inc.
10 Maguire Road Bldg 3 First Floor
Lexington,  MA  02421
Applicant Contact Rakesh Lal
Correspondent
Hogan Lovells
555 13th St. NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
IKN   LEL   MWI  
Date Received11/13/2017
Decision Date 05/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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