GE Vingmed Ultrasound AS

Address:STRANDPROMENADEN 45,HORTEN Vestfold,NO

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, imaging, pulsed doppler, ultrasonic (IYN) (10) System, imaging, pulsed echo, ultrasonic (IYO) (10) Transducer, ultrasonic, diagnostic (ITX) (10) Catheter, ultrasound, intravascular (OBJ) (4)

Premarket Exempt

Clear

Vivid - 00195278505170 Catalog Number :

Device Description : Vivid S70N v206 China

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

Vivid - 00195278505187 Catalog Number :

Device Description : Vivid S60N v206 China

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

Vivid - 00195278505255 Catalog Number :

Device Description : Vivid S70N v206 NOR

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

Vivid - 00195278505316 Catalog Number :

Device Description : Vivid S60N v206 NOR

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

Vivid - 00195278505330 Catalog Number :

Device Description : Vivid E95 v206

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : OBJ, ITX, IYO, IYN

Prescription Use : No

Device Count : 1

Vivid - 00195278505347 Catalog Number :

Device Description : Vivid E80 v206

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, OBJ, IYN, IYO

Prescription Use : No

Device Count : 1

Vivid - 00195278505354 Catalog Number :

Device Description : Vivid E90 v206

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : OBJ, IYN, IYO, ITX

Prescription Use : No

Device Count : 1

Vivid - 00195278516312 Catalog Number :

Device Description : Vivid S70N S60N v203 v204 v205 to v206 Upg kit

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

Vivid - 00195278516343 Catalog Number :

Device Description : Vivid E95, E90, E80 v203 v204 to v206 UPG

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, OBJ, IYO, IYN

Prescription Use : No

Device Count : 1

Vivid - 00840682102698 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

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