FDA 510(k) Application Details - K212160

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K212160
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	Nanowear Inc. 53 Boerum Place, Suite 3F Brooklyn, NY 11201 US Other 510(k) Applications for this Company
Contact	Venkatesh Varadan Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2021
Decision Date	09/22/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review