FDA Registration Active 🇳🇴 Norway

autoSCORE (V 2)

Reg #: 3030646118 · FEI: 3030646118 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
HOLBERG EEG AS
Registration Number
3030646118
FEI Number
3030646118
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Fjosangerveien 70 A, 5068 Bergen
City
Bergen Hordaland
Country
NO

Regulatory Submissions

510(k) Number
K243743

Owner / Operator

Firm Name
Holberg EEG AS
Operator Number
10090411
Address
Fjosangerveien 70 A, 5068 Bergen
City
Bergen
State
NO-NOTA
Postal Code
5068
Country
NO
Correspondent
Smriti Franklin

US Agent

Business Name
Natus Middleton
Contact Name
Douwe VanDenBrink
Address
3150 Pleasant View Road, Middleton
City
Middleton
State
WI
ZIP
53562
Country
US
Phone
608 8298500

Products

Device Name Product Code
Automatic Event Detection Software For Full-Montage Electroencephalograph OMB

Proprietary Names

autoSCORE (V 2)

Establishment Types

Manufacture Medical Device