Duns Number:933200842
Device Description: The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-36 Board onto a single board, meaning the Digital Reference Selection and Analog to Digital Conversion for 32 electrodes is combined into a single slot.
Catalog Number
31-0605-0117
Brand Name
ATLAS COMBO BOARD
Version/Model Number
ATLAS COMBO BOARD
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
f18a0497-1704-40ce-9ad6-08c17c62d113
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 |