Duns Number:809217487
Device Description: The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive func The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
Catalog Number
-
Brand Name
Brain Gauge MD
Version/Model Number
1.0
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PTY
Product Code Name
Computerized Cognitive Assessment Aid, Exempt
Public Device Record Key
57e6cf00-1be5-407a-9d38-41299cd64a49
Public Version Date
April 23, 2019
Public Version Number
2
DI Record Publish Date
November 27, 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. | 1 |