HUMANSCAN CO.,LTD

Address:15, Emtibeuibuk-ro 137beon-gil,Siheung-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

Transducer, Ultrasonic, Diagnostic (ITX) (4) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1)

Premarket Exempt

No Yes

Clear

HUMANSCAN - 08809476810265 Catalog Number : 500395

Device Description : S1-4-D Ultrasound Probe

Device Class : 2

Duns Number: 688299635

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

HUMANSCAN - 08809476810272 Catalog Number : 500395

Device Description : S2-5-D Ultrasound Probe

Device Class : 2

Duns Number: 688299635

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

HUMANSCAN - 08809476810289 Catalog Number : 500395

Device Description : P8D Ultrasound Probe

Device Class : 2

Duns Number: 688299635

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

HUMANSCAN - 08809476810296 Catalog Number : 500395

Device Description : L6-24-D Ultrasound Probe

Device Class : 2

Duns Number: 688299635

Premarket Exempt : Yes

Product Code : ITX, IYO, IYN

Prescription Use : No

Device Count : 1

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