FDA 510(k) Application Details - K071802

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K071802
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH 13605 W. 7TH AVE. GOLDEN, CO 80401-4604 US Other 510(k) Applications for this Company
Contact	ROBERT N CLARK 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	07/02/2007
Decision Date	11/09/2007
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