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 Echo, Ultrasonic (IYO) (4) Transducer, Ultrasonic, Diagnostic (ITX) (4) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (2) Stethoscope, Electronic (DQD) (1)

Premarket Exempt

No Yes

Clear

Binaural Headset - Refurbished - 09353278000489 Catalog Number :

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : DQD

Prescription Use : Yes

Device Count : 1

Kosmos Torso-One - USB - 09353278000502 Catalog Number :

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Kosmos Lexsa - 09353278000519 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

EchoNous System (Refurbished) - 09353278000526 Catalog Number :

Device Description : General ultrasound imaging system, battery-powered

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

EchoNous System - 09353278000533 Catalog Number :

Device Description : General ultrasound imaging system, battery-powered

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

EchoNous System (Refurbished) - 09353278000540 Catalog Number :

Device Description : General ultrasound imaging system, battery-powered

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Kosmos Torso-One - USB - 09353278000571 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 OTS - 09353278000588 Catalog Number :

Device Description : Ultrasound imaging system application software

Device Class : 2

Duns Number: 080481089

Premarket Exempt : No

Product Code : IYO, IYN

Prescription Use : Yes

Device Count : 1

Kosmos Hub - 09353278000595 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

Uscan Linear Probe - 09353278000601 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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