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) (5) Transducer, Ultrasonic, Diagnostic (ITX) (5)

Premarket Exempt

Clear

SC1 - 08800076600119 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

eZ1L - 08800076600126 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

Sono Champion - 08800076600133 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

Sono Changer - 08800076600140 Catalog Number :

Device Class : 2

Duns Number: 689841519

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

Sono dot AI - 08800076600157 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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