SimpleSENSE Platform

Transmitters And Receivers, Electrocardiograph, Telephone

Nanowear Inc.

The following data is part of a premarket notification filed by Nanowear Inc. with the FDA for Simplesense Platform.

Pre-market Notification Details

Device IDK212160
510k NumberK212160
Device Name:SimpleSENSE Platform
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant Nanowear Inc. 53 Boerum Place, Suite 3F Brooklyn,  NY  11201
ContactVenkatesh Varadan
CorrespondentVenkatesh Varadan
Nanowear Inc. 53 Boerum Place, Suite 3F Brooklyn,  NY  11201
Product CodeDXH  
Subsequent Product CodeBZQ
Subsequent Product CodeDPS
Subsequent Product CodeDQD
Subsequent Product CodeDSB
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-12
Decision Date2021-09-22

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