Duns Number:933200842
Device Description: The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an el The ATLAS High Density Signal Splitter (HDSS) is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiological System (K110967) by Neuralynx, Inc. but also the Quantum Amplifier by Natus Corporation. The ATLAS HDSS shares the buffered outputs from the electrode interface and routes them to both systems to be digitized.
Catalog Number
31-0602-0031
Brand Name
ATLAS HDSS
Version/Model Number
ATLAS HDSS
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
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
df849dd6-d48b-40fe-a20f-ed3c32f79ec1
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 |