Duns Number:933200842
Device Description: The ATLAS Headbox is a clinical headbox that allows ECoG electrodes with 1.5mm Touch-Proof The ATLAS Headbox is a clinical headbox that allows ECoG electrodes with 1.5mm Touch-Proof Connector Adapters to interface with the ATLAS Neurophysiology System.
Catalog Number
31-0601-0007
Brand Name
ATLAS HEADBOX
Version/Model Number
ATLAS HEADBOX
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
K110967
Product Code
OMC
Product Code Name
Reduced- Montage Standard Electroencephalograph
Public Device Record Key
6732f293-d1bb-422f-877d-2337b5f6570e
Public Version Date
March 06, 2020
Public Version Number
1
DI Record Publish Date
February 27, 2020
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. | 50 |