Duns Number:119127942
Device Description: A Speech Generating Device with Eyegaze access. A deployed Surface Pro Windows use by peo 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.
Catalog Number
750547
Brand Name
Tobii Dynavox
Version/Model Number
EM-12
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILQ
Product Code Name
System, Communication, Powered
Public Device Record Key
97628290-45f0-453b-a3b6-a1b0bcfd9e68
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 30, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |