FDA 510(k) Application Details - K201764

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K201764
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Draeger Medical Systems, Inc. 6 Tech Dr. Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Tom Hirte Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2020
Decision Date	12/09/2021
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