FDA Registration Active 🇳🇱 Netherlands

Expression IP5 Information Portal

Reg #: 3003768277 · FEI: 3002807880 · Expires 2025
Products
1
Proprietary Names
29
Establishment Types
1
Classifications
1

Registration Details

Registration Name
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Registration Number
3003768277
FEI Number
3002807880
Status
Active
Expiry Year
2025
Initial Importer
No
Address
VEENPLUIS 6
City
BEST Noord-Brabant
Country
NL

Regulatory Submissions

510(k) Number
K131382

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
Maria Heiling
Address
3721 Valley Centre Dr. Ste. 500
City
San Diego
State
CA
ZIP
92130
Country
US
Phone
858 2487651

Products

Device Name Product Code
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

Proprietary Names

Expression IP5 Information Portal Expression MR200 MRI Patient Monitoring System NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181 Wireless SpO2 Patient Module - 989803183541 NiBP Cuff, Single Lumen, Adult - 989803182641 NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211 NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671 NiBP Cuff, Single Lumen, Infant - 989803182611 NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591 NiBP Cuff, Single Lumen, Pediatric - 989803182621 NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531 Advanced Apps ECG Cable - 989803176381 NiBP Cuff, Single Lumen, Thigh - 989803182681 NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171 NiBP Cuff, Single Lumen, Adult-L - 989803182651 NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571 NiBP Cuff, Single Lumen, Small Adult - 989803182631 NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561 NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581 Expression IP5 Software Upgrade - 989803197491 NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191 NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551 NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521 Expression MR Wireless ECG Patient Module - 989803183661 NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201 NiBP Cuff, Single Lumen, Adult, Disp - 989803182541 NiBP Cuff, Single Lumen, Lrg Adult - 989803182661 NiBP Cuff, Single Lumen, Infant, Disp - 989803182511 Expression MR200 New MRI Monitor Accessories - 866177

Establishment Types

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