Intellivue Patient Monitor 510(k) FDA Premarket Notification K150310 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH

Device ID	K150310
510k Number	K150310
Device Name:	IntelliVue Patient Monitor
Classification	Detector And Alarm, Arrhythmia
Applicant	PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE 71034
Contact	Johannes Schmid
Correspondent	Johannes Schmid PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE 71034
Product Code	DSI
Subsequent Product Code	BZC
Subsequent Product Code	BZQ
Subsequent Product Code	CBQ
Subsequent Product Code	CBR
Subsequent Product Code	CBS
Subsequent Product Code	CCK
Subsequent Product Code	CCL
Subsequent Product Code	DPS
Subsequent Product Code	DQA
Subsequent Product Code	DRG
Subsequent Product Code	DRJ
Subsequent Product Code	DRQ
Subsequent Product Code	DRS
Subsequent Product Code	DRT
Subsequent Product Code	DRW
Subsequent Product Code	DSA
Subsequent Product Code	DSF
Subsequent Product Code	DSH
Subsequent Product Code	DSJ
Subsequent Product Code	&nb
CFR Regulation Number	870.1025 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Special
3rd Party Reviewed	No
Combination Product	No
Date Received	2015-02-09
Decision Date	2015-05-13

IntelliVue Patient Monitor