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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
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