Tobii Dynavox L L C

FDA Filings

This page includes the latest FDA filings for Tobii Dynavox L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005301283
• FEI Number: 3005301283
• Name: TOBII TECHNOLOGY AB
• Owner & Operator: Tobii Dynavox LLC
• Contact Address: 2100 Wharton Street Suite 400; Pittsburgh PA 15203 US
• Official Correspondent:
  • Tony J Pavlik
  • x-412-2227957-x
• US Agent:
  • Anthony Pavlik
  • Tobii Dynavox
  • 412 2227957
  • tony.pavlik@tobiidynavox.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: KARLSROVAGEN 2D ; DANDERYD Stockholms lan [SE-01], SE18253 SE
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3004959902
• FEI Number: 3004959902
• Name: Tobii Dynavox LLC
• Owner & Operator: Tobii Dynavox LLC
• Contact Address: 2100 Wharton Street Suite 400; Pittsburgh PA 15203 US
• Official Correspondent:
  • Tony Pavlik
  • x-412-2227957-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2100 Wharton St Ste 400 ; Pittsburgh, PA 15203 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 07340074602124 TOBII DYNAVOX LLC	Tobii Dynavox 521100	2024-09-16
GUDID 07340074602094 TOBII DYNAVOX LLC	Tobii Dynavox 1000800	2024-09-16
GUDID 07340074602070 TOBII DYNAVOX LLC	Tobii Dynavox 750581	2024-09-16
GUDID 07340074602056 TOBII DYNAVOX LLC	Tobii Dynavox 750580	2024-09-16
GUDID 07340074602032 TOBII DYNAVOX LLC	Tobii Dynavox 750579	2024-09-16
GUDID 07340074602001 TOBII DYNAVOX LLC	Tobii Dynavox 1000255	2023-05-12
GUDID 07340074601998 TOBII DYNAVOX LLC	Tobii Dynavox 1000254	2023-05-12
GUDID 07340074601202 TOBII DYNAVOX LLC	Tobii Dynavox 12006939	2023-05-12
GUDID 07340074601929 TOBII DYNAVOX LLC	Tobii Dynavox 113527	2022-09-09
GUDID 07340074601714 TOBII DYNAVOX LLC	Tobii Dynavox 750567	2022-03-02
GUDID 07340074601769 TOBII DYNAVOX LLC	Tobii Dynavox 750563	2021-11-23
GUDID 07340074601806 TOBII DYNAVOX LLC	Tobii Dynavox 801300	2020-08-07
GUDID 07340074601110 TOBII DYNAVOX LLC	Tobii Dynavox 12006977	2020-03-04
GUDID 07340074601035 TOBII DYNAVOX LLC	Tobii Dynavox 12006976	2020-03-04
GUDID 07340074601516 TOBII DYNAVOX LLC	Tobii Dynavox 12006977	2019-10-29
GUDID 07340074601509 TOBII DYNAVOX LLC	Tobii Dynavox 12006977	2019-10-29
GUDID 07340074601141 TOBII DYNAVOX LLC	Tobii Dynavox 750547	2018-10-01
GUDID 07340074601479 TOBII DYNAVOX LLC	Tobii Dynavox 800746	2018-09-27
GUDID 07340074601462 TOBII DYNAVOX LLC	Tobii Dynavox 800745	2018-09-27
GUDID 07340074601455 TOBII DYNAVOX LLC	Tobii Dynavox 800744	2018-09-27
GUDID 07340074601448 TOBII DYNAVOX LLC	Tobii Dynavox 800743	2018-09-27
GUDID 07340074601431 TOBII DYNAVOX LLC	Tobii Dynavox 800742	2018-09-27
GUDID 07340074601424 TOBII DYNAVOX LLC	Tobii Dynavox 800741	2018-09-27
GUDID 07340074601417 TOBII DYNAVOX LLC	Tobii Dynavox 800740	2018-09-27
GUDID 07340074601400 TOBII DYNAVOX LLC	Tobii Dynavox 800739	2018-09-27
GUDID 07340074601394 TOBII DYNAVOX LLC	Tobii Dynavox 800738	2018-09-27
GUDID 07340074601387 TOBII DYNAVOX LLC	Tobii Dynavox 800716	2018-09-27
GUDID 07340074601370 TOBII DYNAVOX LLC	Tobii Dynavox 800715	2018-09-27
GUDID 07340074601363 TOBII DYNAVOX LLC	Tobii Dynavox 800714	2018-09-27
GUDID 07340074601356 TOBII DYNAVOX LLC	Tobii Dynavox 800713	2018-09-27
GUDID 07340074601349 TOBII DYNAVOX LLC	Tobii Dynavox 800712	2018-09-27
GUDID 07340074601332 TOBII DYNAVOX LLC	Tobii Dynavox 800711	2018-09-27
GUDID 07340074601325 TOBII DYNAVOX LLC	Tobii Dynavox 800710	2018-09-27
GUDID 07340074601318 TOBII DYNAVOX LLC	Tobii Dynavox 800709	2018-09-27
GUDID 07340074601301 TOBII DYNAVOX LLC	Tobii Dynavox 800708	2018-09-27
GUDID 07340074601042 TOBII DYNAVOX LLC	Tobii Dynavox 750518	2018-06-15
GUDID 07340074600298 TOBII DYNAVOX LLC	Tobii Dynavox 750423	2018-05-15
GUDID 07340074600281 TOBII DYNAVOX LLC	Tobii Dynavox 750394	2018-05-15
GUDID 07340074600410 TOBII DYNAVOX LLC	Tobii Dynavox 12004860	2018-03-29
GUDID 07340074600397 TOBII DYNAVOX LLC	Tobii Dynavox	2018-03-29
GUDID 07340074600335 TOBII DYNAVOX LLC	Tobii Dynavox	2018-03-29
GUDID 07340074600328 TOBII DYNAVOX LLC	Tobii Dynavox	2018-03-29
GUDID 07340074600304 TOBII DYNAVOX LLC	Tobii Dynavox 750471	2018-03-29
GUDID 07340074600274 TOBII DYNAVOX LLC	Tobii Dynavox	2018-03-29
GUDID 07340074600267 TOBII DYNAVOX LLC	Tobii Dynavox	2018-03-29
ILQ Tobii Dynavox LLC	T7	2014-05-01
ILQ Tobii Dynavox LLC	T15	2014-05-01
ILQ Tobii Dynavox LLC	T10	2014-05-01
ILQ Tobii Dynavox LLC	SC Tablet	2014-05-01
ILQ Tobii Dynavox LLC	SC Pro Tablet	2014-05-01
ILQ Tobii Dynavox LLC	Indi 7	2014-05-01
ILQ Tobii Dynavox LLC	I-16	2014-05-01
ILQ Tobii Dynavox LLC	I-15	2014-05-01
ILQ Tobii Dynavox LLC	I-15+	2014-05-01
ILQ Tobii Dynavox LLC	I-13	2014-05-01
ILQ Tobii Dynavox LLC	I-12	2014-05-01
ILQ Tobii Dynavox LLC	I-12+	2014-05-01
ILQ Tobii Dynavox LLC	I-110	2014-05-01
ILQ Tobii Dynavox LLC	EM-12	2014-05-01
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	T7	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	T15	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	T10	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	Indi	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	Indi 7	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	I-16	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	I-15	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	I-15+	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	I-13	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	I-12	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	I-12+	2005-08-12
ILQ TOBII TECHNOLOGY AB [Tobii Dynavox LLC]	I-110	2005-08-12

Related Finance Registrations

NCAGE Code	35ZV7	TOBII DYNAVOX LLC!DBA TOBII DYNAVOX
CAGE Code	35ZV7	TOBII DYNAVOX LLC TOBII DYNAVOX
S.A.M. Registration	35ZV7 [119127942]	TOBII DYNAVOX LLC TOBII DYNAVOX

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092615743	Taipei,China (Taiwan) -> Los Angeles, California	COMPUTER SYSTEM GIBBON GAZE	48 CTN
2020092615793	Taipei,China (Taiwan) -> Los Angeles, California	INDUSTRIAL CONTROL UNIT DEPARTURE ONYX GIBBON PACKAGE CASE CONTENTS	15 CTN
2020092659986	Taipei,China (Taiwan) -> Los Angeles, California	COMPUTER SYSTEM GIBBON GAZE MODEL	36 CTN
2020090464871	Taipei,China (Taiwan) -> Los Angeles, California	COMPUTER SYSTEM GIBBON GAZE	48 CTN
2020090464945	Taipei,China (Taiwan) -> Los Angeles, California	INDUSTRIAL CONTROL UNIT DEPARTURE ONYX GIBBON PACKAGE CASE CONTENTS	15 CTN
2020081825399	Yantian,China (Mainland) -> Los Angeles, California	ADAPTER	15 CTN
2020081142284	Yantian,China (Mainland) -> Los Angeles, California	ADAPTER	15 CTN
2020080358614	Yantian,China (Mainland) -> Los Angeles, California	ADAPTER	15 CTN