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) (9)

Premarket Exempt

Clear

Voluson - 00195278473028 Catalog Number : Voluson-Signature-to-BT22-UPG

Device Description : Voluson Signature to BT22 UPG

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, IYO

Prescription Use : No

Device Count : 1

Voluson - 00195278473042 Catalog Number : VOLUSON-S10Expert-BT22

Device Description : Voluson S10 Expert BT22

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : No

Device Count : 1

Voluson - 00195278473059 Catalog Number : VOLUSON-S10-BT22

Device Description : Voluson S10 BT22

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

Voluson - 00195278473066 Catalog Number : VOLUSON-S8t-BT22

Device Description : Voluson S8t BT22

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

Voluson - 00195278473073 Catalog Number : VOLUSON-S8-BT22

Device Description : Voluson S8 BT22

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

Voluson - 00195278473080 Catalog Number : VOLUSON-S6-BT22

Device Description : Voluson S6 BT22

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : No

Device Count : 1

Voluson - 00195278473097 Catalog Number : VOLUSON-P6-BT22

Device Description : Voluson P6 BT22

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

Voluson - 00195278473103 Catalog Number : VOLUSON-P8-BT22

Device Description : Voluson P8 BT22

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

LOGIQ - 00195278487414 Catalog Number :

Device Description : LOGIQ E10s R2 to R3 UPG

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

Voluson - 00840682104166 Catalog Number :

Device Class : 2

Duns Number: 690168810

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

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