GE Ultrasound Korea Ltd.

GE Ultrasound Korea Ltd.

Address:9, Sunhwan-ro 214beon-gil, Jungwon-gu,Seongnam-Si Gyeonggi,KR

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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)

Premarket Exempt

No

Clear

VOLUSON - 00195278006820 Catalog Number :

Device Description : VOLUSON SWIFT+ CONSOLE ASSY

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

Voluson - 00195278006837 Catalog Number :

Device Description : VOLUSON SWIFT CONSOLE ASSY

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

LOGIQ - 00195278029010 Catalog Number :

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

LOGIQ - 00195278111241 Catalog Number :

Device Description : LOGIQ P8 R4

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

LOGIQ - 00195278111258 Catalog Number :

Device Description : LOGIQ P9 R4

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

LOGIQ - 00195278111265 Catalog Number :

Device Description : LOGIQ P10 R4

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

LOGIQ - 00195278111272 Catalog Number :

Device Description : LP9 R3 to R4 SW Conversion

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

LOGIQ - 00195278236005 Catalog Number :

Device Description : LOGIQ P10 R4 HD

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

LOGIQ - 00195278405326 Catalog Number :

Device Description : LOGIQ Fortis HDU Console

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

LOGIQ - 00195278405333 Catalog Number :

Device Description : LOGIQ Fortis LCD Console

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

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