FDA Registration Active 🇳🇱 Netherlands

8 Channel High Resolution Brain Coil

Reg #: 3003768277 · FEI: 3002807880 · Expires 2025
Products
1
Proprietary Names
8
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
K013159

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
Coil, Magnetic Resonance, Specialty MOS

Proprietary Names

8 Channel High Resolution Brain Coil Philips 1.5T SENSE Intera 8 Ch Head Coil GE 1.5T HDMR2-VALUE 8C HEAD / BRAIN, MA Head Coil, GE 1.5T LXI 8C HEAD (OEM) HD 8Ch HiRes Brain Array (Receive Only) SENSE Head Coil 1.5T/8CH GE 1.5T 8C HEAD / BRAIN COIL VALUE 8Ch High Resolution Brain Array (Receive Only) 1.5T HD 8HR Brain Array for HDe (Receive Only)

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility