TOBII DYNAVOX LLC

Address:2100 Wharton St Ste 400,Pittsburgh,PA,15203,US

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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 - 07340074601042 Catalog Number : 750518

Device Description : Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox so Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox software includes Snap+Corefirst, Compass or Communicator software.

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601110 Catalog Number : 12006977

Device Description : Speech Generating Device with Eye Tracking - 16" screen.

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601141 Catalog Number : 750547

Device Description : A Speech Generating Device with Eyegaze access. A deployed Surface Pro Windows A Speech Generating Device with Eyegaze access. A deployed Surface Pro Windows use by people with severe speech impairment and physical limitations. The deployment included speech software from Tobii Dynavox including Snap+Core First.

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601301 Catalog Number : 800708

Device Description : SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/SILVER TABLET

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601318 Catalog Number : 800709

Device Description : SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/GOLD TABLET

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601325 Catalog Number : 800710

Device Description : SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/SPACE GRAY TABLET

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601332 Catalog Number : 800711

Device Description : SC TABLET, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/SILVER TABLET

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601349 Catalog Number : 800712

Device Description : SC TABLET, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/GOLD TABLET

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601356 Catalog Number : 800713

Device Description : SC TABLET, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/SPACE GRAY TABLET

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

Tobii Dynavox - 07340074601363 Catalog Number : 800714

Device Description : SC TABLET, SGD, WITH SNAP + CORE FIRST, RASPBERRY SC/SILVER TABLET

Device Class : 2

Duns Number: 119127942

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : No

Device Count : 1

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