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 - 07540205000540 Catalog Number : 99-02-00003; 50-02-00003

Device Description : Clarius brand C3-45 scanner

Device Class :

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000557 Catalog Number : 99-02-00005; 50-02-00005

Device Description : Clarius brand C7 scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000564 Catalog Number : 99-02-00006; 50-02-00006

Device Description : Clarius brand L7

Device Class :

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000595 Catalog Number : 99-02-00009; 50-02-00003

Device Description : Clarius brand C3 Premium scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000601 Catalog Number : 99-02-00010; 50-02-00005

Device Description : Clarius brand C7 Premium scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000618 Catalog Number : 99-02-00011; 50-02-00006

Device Description : Clarius brand L7 Premium scanner

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Viera Portable Breast Ultrasound - 07540205000670 Catalog Number : 81-02-00011; 50-02-00006

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Viera Portable Breast Ultrasound - 07540205000687 Catalog Number : 81-02-00023; 81-02-00001

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Viera Portable Breast Ultrasound - 07540205000694 Catalog Number : 81-02-00024; 81-02-00002

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000724 Catalog Number : 99-02-00028

Device Description : Clarius Fan

Device Class : 2

Duns Number: 202522751

Premarket Exempt : Yes

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

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