FDA 510(k) Application Details - K211651

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K211651
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	Spacelabs Healthcare Ltd. Unit B, Foxholes Centre, John Tate Road Hertford SG13 7DT GB Other 510(k) Applications for this Company
Contact	Roger Moldon Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2021
Decision Date	11/22/2021
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