FDA 510(k) Application Details - K212143

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K212143
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	Neteera Technologies Ltd. Hebrew University Givat Ram Campus, High-tech Village - building 1.1/ P.O. Prof Rokah 2 Jerusalem 9518702 IL Other 510(k) Applications for this Company
Contact	Yael Himmel Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2021
Decision Date	09/28/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review