FDA Registration Active 🇨🇦 Canada

IntelliVue Patient Monitors

Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Philips Electronics Ltd
Registration Number
3000126629
FEI Number
3000126629
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1875 Buckhorn Gate, 5th Floor
City
Mississauga Ontario
Country
CA

Regulatory Submissions

510(k) Number
K060221

Owner / Operator

Firm Name
Philips Medical Systems International BV
Operator Number
1217116
Address
Veenpluis 6
City
Best
State
NL-NOTA
Postal Code
5684PC
Country
NL

US Agent

Business Name
Philips
Contact Name
Shaylee Masilunas
Address
6501 Living Place
City
Pittsburgh
State
PA
ZIP
15206
Country
US
Phone
724 8162019

Products

Device Name Product Code
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

Proprietary Names

IntelliVue Patient Monitors Philips Sample Line W HUMID Kit, M2777A Philips PED Oral Nas CO2 O2 Can, M2761A CO2 Nasal Cannula - Pediatric Philips ADU Oral Nas CO2 O2 Can, M2760A Philips ADU PED Airway Adapter, M2768A Philips ADU Nasal CO2 Cannula, M2744A Philips ADU Nasal CO2 O2 Cannula, M2750A Philips PED INF Airway Adapter Philips ADU PED A ADPTR W Humid, M2772A Philips INF Nasal CO2 O2 Cannula CO2 Nasal Cannula - Infant Philips Sample Line Kit, M2776A Philips PED Oral Nasal CO2 Can, M2757A Philips PED INF A ADPTR W HUMID, M2773A Philips PED Nasal CO2 O2 Cannula, M2751A Philips ADU Oral Nasal CO2 Can, M2756A

Establishment Types

Export Device to the United States But Perform No Other Operation on Device