Duns Number:933200842
Device Description: The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an MDR-68 connector to interface with the ATLAS Neurophysiology System. The ATLAS HD Headbox allows two MDR-68 connectors to be tied in parallel and a switch to disable active driven ground supplied by the ATLAS Neurophysiology system.
Catalog Number
31-0601-0131
Brand Name
ATLAS HD HEADBOX
Version/Model Number
ATLAS HD 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
05104d3b-9060-4b64-beec-2ec5baf0e581
Public Version Date
November 15, 2021
Public Version Number
1
DI Record Publish Date
November 05, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |