ALPINION MEDICAL SYSTEMS CO.,LTD

ALPINION MEDICAL SYSTEMS CO.,LTD

Address:4F, 15, Magokjungang 14-ro,Gangseo-gu Seoul,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

L3-12 - 08800013510006 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

L3-12H - 08800013510013 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

L3-8 - 08800013510020 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

L3-12HWD - 08800013510037 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : No

Device Count : 1

L3-12i - 08800013510044 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

L3-8i - 08800013510051 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

L8-17X - 08800013510068 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

L3-12X - 08800013510075 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

L8-17i - 08800013510082 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

IO3-12 - 08800013510099 Catalog Number :

Device Class : 2

Duns Number: 557800655

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

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