Duns Number:021063219
Device Description: Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acqui Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acquisition System.
Catalog Number
AE-120A
Brand Name
VitalEEG Portable System
Version/Model Number
AE-120A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K183529
Product Code
OMC
Product Code Name
Reduced- Montage Standard Electroencephalograph
Public Device Record Key
34ebe215-3b58-424c-93f8-01188bfc6c2e
Public Version Date
May 24, 2021
Public Version Number
2
DI Record Publish Date
March 29, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 393 |