FDA Registration Active 🇩🇪 Germany

PHILIPS Masimo CO2 Module

Reg #: 9610816 · FEI: 3002807167 · Expires 2025
Products
8
Proprietary Names
5
Establishment Types
2
Classifications
8

Registration Details

Registration Name
Philips Medizin Systeme Boeblingen GmbH
Registration Number
9610816
FEI Number
3002807167
Status
Active
Expiry Year
2025
Initial Importer
No
Address
HEWLETT-PACKARD STRASSE 2
City
BOEBLINGEN Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K192137

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
Deborah Currlin
Address
222 Jacobs Street
City
Cambridge
State
MA
ZIP
02141
Country
US
Phone
858 9452753

Products

Device Name Product Code
Monitor, St Segment With Alarm MLD
Alarm, Blood-Pressure DSJ
Detector And Alarm, Arrhythmia DSI
Computer, Diagnostic, Pre-Programmed, Single-Function DXG
Probe, Thermodilution KRB
Computer, Blood-Pressure DSK
System, Measurement, Blood-Pressure, Non-Invasive DXN
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

Proprietary Names

PHILIPS Masimo CO2 Module PHILIPS Masimo O3 Module ISA CO2 Measurement Device Masimo O3 Measurement Device IRMA CO2 Measurement Device

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility