Duns Number:933200842
Device Description: The HS-18-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usual The HS-18-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usually consisting of up to 16 electrodes) to interface with the ATLAS Neurophysiology System.
Catalog Number
HS-18-CHET-A 1.0
Brand Name
ATLAS-HS-18-CHET-A 1.0
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
K110967
Product Code
OMC
Product Code Name
Reduced- Montage Standard Electroencephalograph
Public Device Record Key
560bab2c-3ff0-4e1a-81ea-7e6480f2ebf7
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
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 |