Clarius Mobile Health Corp

Address:16192 Coastal Hwy,Lewes,DE,19958,US

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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 Yes

Clear

Clarius Ultrasound Scanner - 07540205001103 Catalog Number : 99-03-00021, 99-13-00008

Device Description : Clarius charger

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001127 Catalog Number : 99-02-00069, 99-13-00006

Device Description : High-density transducer type – endocavity array (Clarius Scanner EC7 HD)

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001158 Catalog Number : 99-03-00005, 50-02-00061

Device Description : Clarius fan

Device Class : 2

Duns Number: 202522751

Premarket Exempt : Yes

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001189 Catalog Number : 99-13-00018, 99-02-00074

Device Description : Portable Ultrasound Scanner

Device Class :

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001196 Catalog Number : 99-13-00020, 99-02-00077

Device Description : Portable Ultrasound Scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001202 Catalog Number : 99-13-00019, 99-02-00075

Device Description : Portable Ultrasound Scanner.

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001219 Catalog Number : 99-13-00024, 99-02-00076

Device Description : Portable Ultrasound Scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001226 Catalog Number : 99-13-00021, 99-02-00078

Device Description : Portable Ultrasound Scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001233 Catalog Number : 99-13-00023, 99-02-00080

Device Description : Portable Ultrasound Scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001240 Catalog Number : 99-13-00022, 99-02-00079

Device Description : Portable Ultrasound Scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

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