FDA 510(k) Application Details - K130208

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K130208
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	CARDIOPULMONARY CORP. 200 CASCADE BLVD. MILFORD, CT 06460 US Other 510(k) Applications for this Company
Contact	UREY KANG 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	01/28/2013
Decision Date	12/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review