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.

Pre-market Notification Details

Device IDK201669
510k NumberK201669
Device Name:SimpleSENSE
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant Nanowear Inc. 53 Boerum Place, Suite 3F Brooklyn,  NY  11201
ContactVenkatesh Varadan
CorrespondentMelissa Walker
Graematter, Inc. 1324 Clarkson Clayton Ctr, #332 St Louis,  MO  63011
Product CodeDXH  
Subsequent Product CodeBZQ
Subsequent Product CodeDPS
Subsequent Product CodeDQD
Subsequent Product CodeDSB
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-19
Decision Date2020-11-06

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