FCU

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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) (10) Transducer, Ultrasonic, Diagnostic (ITX) (10)

Premarket Exempt

Clear

eZono1000 - 08800076600010 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

Sonovation1L - 08800076600027 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

SOFRA1L - 08800076600034 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

SonoInfra1L - 08800076600041 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

Dr.SAFE - 08800076600058 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

ACUFRIEND - 08800076600065 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

ACUGUIDE - 08800076600072 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

ACUWAY - 08800076600089 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

AcuViz Pocket - 08800076600096 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

Sono Cloud 1 - 08800076600102 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

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