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 - 07540205000854 Catalog Number : 99-02-00039; 50-02-00033; 50-02-00039

Device Description : Mobile cart with multi-port battery charger

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000878 Catalog Number : 99-03-00019; 50-02-00039

Device Description : Multi-port lithium ion battery charger

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000991 Catalog Number : 99-02-00040, 99-13-00002

Device Description : High-density transducer type – curvilinear array (Clarius Scanner C3 HD)

Device Class :

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001004 Catalog Number : 99-02-00073, 99-13-00014

Device Description : High-density transducer type - high-frequency linear array (Clarius Scanner L20 HD)

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001011 Catalog Number : 99-02-00042, 99-13-00003

Device Description : High-density transducer type – micro-curvilinear array (Clarius Scanner C7 HD)

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001028 Catalog Number : 99-03-00022, 99-13-00016

Device Description : The Clarius 2-in-1 Charging Station HD is a charging station that combines a doc The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for charging HD Scanners, that has a separate port for charging a spare HD battery.

Device Class : 2

Duns Number: 202522751

Premarket Exempt : Yes

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001035 Catalog Number : 99-02-00044, 99-13-00004

Device Description : High-density transducer type – linear array (Clarius Scanner L7 HD)

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001059 Catalog Number : 99-02-00046, 99-13-00005

Device Description : High-density transducer type – high-frequency linear array (Clarius Scanner L15 HD)

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001073 Catalog Number : 99-02-00048, 99-13-00007

Device Description : High-density veterinary transducer type – phased array (Clarius Scanner PA HD)

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205001097 Catalog Number : 99-03-00020, 99-13-00010

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

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