ECHONOUS, INC.

Address:8310 154th Ave NE,Redmond,WA,98052,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) (3) Transducer, Ultrasonic, Diagnostic (ITX) (3) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) System, Digital Image Communications, Radiological (LMD) (1)

Premarket Exempt

No Yes

Clear

Kosmos Hub (Refurbished) - 09353278000618 Catalog Number :

Device Description : Ultrasound imaging system multi-transducer connection unit

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYN

Prescription Use : Yes

Device Count : 1

Kosmos Lexsa (Refurbished) - 09353278000625 Catalog Number :

Device Description : Ultrasound imaging transducer, hand-held

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Kosmos UP - 09353278000656 Catalog Number :

Device Class : 1

Duns Number: 080481089

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

Kosmos OTS Android Linear - 09353278000687 Catalog Number :

Device Description : Kosmos on Android software application for ultrasound imaging

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : Yes

Device Count : 1

Kosmos OTS Android Linear Color - 09353278000694 Catalog Number :

Device Description : Kosmos on Android software application for ultrasound imaging

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : Yes

Device Count : 1

Uscan Sector Probe - 09369999064082 Catalog Number :

Device Description : Extracorporeal ultrasound imaging system transducer, hand-held

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Uscan Sector Probe (Japan) - 09369999064099 Catalog Number :

Device Description : Extracorporeal ultrasound imaging system transducer, hand-held

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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