Duns Number:313152485
Device Description: eeg cap accessories
Catalog Number
-
Brand Name
waveguard
Version/Model Number
XE-294
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K110223
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
19421f19-f47a-4858-8353-1b43eee3151f
Public Version Date
August 14, 2020
Public Version Number
3
DI Record Publish Date
June 13, 2019
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. | 183 |