FDA Device Entity Profile: Tobii Dynavox LLC

Known Identifiers & Locations

FEI Numbers 3004959902, 3005301283

Owner Operator Numbers 10039853, 9076359

Locations Covered Coraopolis, PA, US; Stockholm, SE

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3004959902	Tobii Dynavox LLC	Coraopolis, PA, US	Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details
3005301283	DYNAVOX Group AB	Stockholm, SE	Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.