FDA Registration Active 🇩🇰 Denmark

GE Vivid I Portable

Reg #: 3009196578 · FEI: 3009196578 · Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3

Registration Details

Registration Name
LBN MEDICAL A/S
Registration Number
3009196578
FEI Number
3009196578
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Gugvej 70
City
Aalborg Nordjylland
Country
DK

Regulatory Submissions

510(k) Number
K092140

Owner / Operator

Firm Name
LBN Medical ApS
Operator Number
10055731
Address
Gugvej 70
City
Aalborg
State
Nordjylland
Postal Code
9210
Country
DK
Correspondent
Jesper K Nielsen

Products

Device Name Product Code
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX

Proprietary Names

GE Vivid I Portable

Establishment Types

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