Duns Number:933200842
Device Description: The Modular Headstage-36 is a clinical headstage that connects to one of several modular e The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology System. The Modular Headstage-36 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
Catalog Number
31-0601-0091
Brand Name
Modular Headstage-36
Version/Model Number
Modular Headstage-36
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
25d14403-9ea5-48cd-b922-f721e8c6ba8d
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 |