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) (8) System, imaging, pulsed echo, ultrasonic (IYO) (8) Transducer, ultrasonic, diagnostic (ITX) (8) System, image processing, radiological (LLZ) (3)

Premarket Exempt

Clear

Vivid - 00840682102735 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

EchoPAC - 00840682103961 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

EchoPAC - 00840682104333 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Vscan - 00840682107853 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Vscan - 00840682107891 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

Vscan - 00840682115384 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

NA - 00840682115582 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

NA - 00840682115599 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : ITX, IYN, LLZ, IYO

Prescription Use : Yes

Device Count : 1

NA - 00840682115612 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

NA - 00840682115636 Catalog Number :

Device Class : 2

Duns Number: 518870571

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

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