FDA 510(k) Application Details - K153739

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K153739
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN OSKAR-VON-MILLER-STR. 6 MAMMENDORF 82291 DE Other 510(k) Applications for this Company
Contact	HANS SCHWAIGER 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	12/28/2015
Decision Date	06/28/2016
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