FDA 510(k) Application Details - K170828

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K170828
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 US Other 510(k) Applications for this Company
Contact	Nicole Bush 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	03/20/2017
Decision Date	05/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review