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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K232053
FOIA Releasable 510(k) K232053
Device Name SimpleSense-BP, SimpleSense-BP Software Application
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 Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
BZQ   DPS   DQD   DSB   DXH  
Date Received07/11/2023
Decision Date 12/08/2023
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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