FDA Registration Active 🇩🇪 Germany

Multi-Measurement Module X3

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
K182979

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
Detector And Alarm, Arrhythmia DSI
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
System, Network And Communication, Physiological Monitors MSX
System, Measurement, Blood-Pressure, Non-Invasive DXN
Computer, Blood-Pressure DSK
Monitor, St Segment With Alarm MLD
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
Alarm, Blood-Pressure DSJ

Proprietary Names

Multi-Measurement Module X3 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, MP5, MP5SC

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device