FDA 510(k) Application Details - K201746

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K201746
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Remote Diagnostic Technologies Limited Pavilion C2, Ashwood Park, Ashwood Way Basingstoke RG23 8BG GB Other 510(k) Applications for this Company
Contact	Timothy Bubb 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	06/26/2020
Decision Date	09/18/2020
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