Establishment Registration & Device Listing

Proprietary Name:	CO2 Nasal Cannula - Infant; CO2 Nasal Cannula - Pediatric; IntelliVue Patient Monitors; Philips ADU Nasal CO2 Cannula, M2744A; Philips ADU Nasal CO2 O2 Cannula, M2750A; Philips ADU Oral Nas CO2 O2 Can, M2760A; Philips ADU Oral Nasal CO2 Can, M2756A; Philips ADU PED A ADPTR W Humid, M2772A; Philips ADU PED Airway Adapter, M2768A; Philips INF Nasal CO2 O2 Cannula; Philips PED INF A ADPTR W HUMID, M2773A; Philips PED INF Airway Adapter; Philips PED Nasal CO2 O2 Cannula, M2751A; Philips PED Oral Nas CO2 O2 Can, M2761A; Philips PED Oral Nasal CO2 Can, M2757A; Philips Sample Line Kit, M2776A; Philips Sample Line W HUMID Kit, M2777A
Classification Name:	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Product Code:	MHX
Device Class:	2
Regulation Number:	870.1025
Medical Specialty:	Cardiovascular
Registered Establishment Name:	Philips Electronics Ltd
Registered Establishment Number:	3000126629
Premarket Submission Number:	K060221
Owner/Operator:	Philips Medical Systems International BV
Owner/Operator Number:	1217116
Establishment Operations:	Foreign Exporter