TOBII DYNAVOX LLC

Address:2100 Wharton St Ste 400,Pittsburgh,PA,15203,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, Communication, Powered (ILQ) (10)

Premarket Exempt

Yes

Clear

Tobii Dynavox - 07340074600267 Catalog Number :

Device Description : Speech Generating Device with Eyegaze (IS 20)

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600274 Catalog Number :

Device Description : Speech Generating Device with Eyegaze (IS 20) 15" Screen

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600281 Catalog Number : 750394

Device Description : Speech Generating Device with 10" screen

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600298 Catalog Number : 750423

Device Description : Speech Generating Device with 15" screen

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600304 Catalog Number : 750471

Device Description : Speech Generating Device with 7" screen

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600328 Catalog Number :

Device Description : Speech Generating Device with Eyegaze (IS 4) 12" Screen

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600335 Catalog Number :

Device Description : Speech Generating Device with Eyegaze (IS4) 15" screen

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600397 Catalog Number :

Device Description : Small, lightweight portable Speech Generating Device with touch screen, Snap or Small, lightweight portable Speech Generating Device with touch screen, Snap or Communicator Software.

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074600410 Catalog Number : 12004860

Device Description : Speech Generating Device with a 10" in touch screen. Tablet style unit, water r Speech Generating Device with a 10" in touch screen. Tablet style unit, water resistant and durable with high quality speakers. Generally includes SNAP, COMPASS or Communicator Software

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601035 Catalog Number : 12006976

Device Description : Speech Generating Device with Eye tracking capability - 13" screen size

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

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