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 - 07540205000311 Catalog Number : 80-02-00014; 50-02-00006

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000328 Catalog Number : 99-02-00018; 50-02-00004

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000335 Catalog Number : 80-02-00001; AR-3500-01B

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000342 Catalog Number : 99-02-00025; 99-02-00014

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Synergy MSK Ultrasound Scanner - 07540205000373 Catalog Number : 80-02-00022; 80-02-00021

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Synergy MSK Ultrasound - 07540205000380 Catalog Number : 80-02-00023; 80-02-00002; AR-3500-01C

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000397 Catalog Number : 12-01-00003

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000403 Catalog Number : 12-01-00004

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Synergy MSK Ultrasound - 07540205000410 Catalog Number : 80-02-00024; 80-02-00001; AR-3500-01B

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Clarius Ultrasound Scanner - 07540205000533 Catalog Number : 99-02-00002

Device Description : Clarius brand Charger

Device Class : 2

Duns Number: 202522751

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

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