FDA 510(k) Application Details - K230214

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K230214
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	Medopad Inc The Genome Center 101 6th Avenue New York, NY 10013 US Other 510(k) Applications for this Company
Contact	Mani Shanmugham Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2023
Decision Date	06/02/2023
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	N
Expedited Review