Healcerion Co., Ltd.

Address:501ho, 11, Gasan digital 2-ro,Geumcheon-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 Echo, Ultrasonic (IYO) (6) Transducer, Ultrasonic, Diagnostic (ITX) (3) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1)

Premarket Exempt

Clear

Sonon - 00860000879804 Catalog Number : 300C

Device Description : Transducer, Ultrasonic, Diagnostic

Device Class : 2

Duns Number: 688732988

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Sonon - 00860000879811 Catalog Number : 300C

Device Description : System, Imaging, Pulse Echo, Ultrasonics

Device Class : 2

Duns Number: 688732988

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Helcerion - 00860000879828 Catalog Number : 300L

Device Description : Transducer, Ultrasonic, Diagnostic

Device Class : 2

Duns Number: 688732988

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Sonon - 00860000879835 Catalog Number : 300L

Device Description : System, Imaging, Pulsed Doppler, Ultrasonic

Device Class : 2

Duns Number: 688732988

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Sonon - 00860000879842 Catalog Number : 300L

Device Description : System, Imaging, Pulsed Echo, Ultrasonic

Device Class : 2

Duns Number: 688732988

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

SONON ULTRASOUND IMAGING SYSTEM - 08809489920005 Catalog Number :

Device Class : 2

Duns Number: 688732988

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

SONON ULTRASOUND IMAGING SYSTEM - 08809489920012 Catalog Number :

Device Class : 2

Duns Number: 688732988

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

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