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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, Electrocardiograph, Telephone
510(k) Number K212160
Device Name SimpleSENSE Platform
Applicant
Nanowear, Inc.
53 Boerum Place, Suite 3f
Brooklyn,  NY  11201
Applicant Contact Venkatesh Varadan
Correspondent
Nanowear, Inc.
53 Boerum Place, Suite 3f
Brooklyn,  NY  11201
Correspondent Contact Venkatesh Varadan
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Codes
BZQ   DPS   DQD   DSB  
Date Received07/12/2021
Decision Date 09/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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