FDA 510(k) Application Details - K223163

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K223163
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	Sleepiz AG Hornbachstrasse 23 Zurich 8008 CH Other 510(k) Applications for this Company
Contact	Marta Stepien 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	10/07/2022
Decision Date	08/18/2023
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	Y
Expedited Review