GE Medical Systems (China) Co.,Ltd.

Address:NO. 19 CHANGJIANG ROAD,WUXI Jiangsu,CN

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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) (3) System, imaging, pulsed echo, ultrasonic (IYO) (3) Transducer, ultrasonic, diagnostic (ITX) (3)

Premarket Exempt

No Yes

Clear

Versana - 00840682180535 Catalog Number :

Device Description : Magna R2 VS Basic console

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Versana - 00840682180542 Catalog Number :

Device Description : Magna R2 VA Basic console

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

NA - 00840682190299 Catalog Number : H48062AJ

Device Description : L4-20t-RS

Device Class : 2

Duns Number: 654658731

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : No

Device Count : 1

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