FDA Registration Active 🇩🇪 Germany

IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800

Reg #: 9610816 · FEI: 3002807167 · Expires 2025
Products
8
Proprietary Names
2
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
K151681

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
System, Measurement, Blood-Pressure, Non-Invasive DXN
Computer, Diagnostic, Pre-Programmed, Single-Function DXG
Detector And Alarm, Arrhythmia DSI
Alarm, Blood-Pressure DSJ
Computer, Blood-Pressure DSK
Monitor, St Segment With Alarm MLD
Amplifier And Signal Conditioner, Transducer Signal DRQ
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

Proprietary Names

IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800 G7m Module

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device