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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K171244
Device Name Physiotrace
Applicant
Nimbleheart, Inc.
1300 White Oaks Rd., Suite #201
Campbell,  CA  95008
Applicant Contact Sonal Tambe
Correspondent
Nimbleheart, Inc.
1300 White Oaks Rd., Suite #201
Campbell,  CA  95008
Correspondent Contact Sonal Tambe
Regulation Number870.2360
Classification Product Code
DRX  
Subsequent Product Codes
MHX   MWI  
Date Received04/28/2017
Decision Date 08/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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