Duns Number:098554157
Device Description: 32 Ch EEG EasyNet Amplifier
Catalog Number
-
Brand Name
Easy Ambulatory
Version/Model Number
190257-200
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K946094
Product Code
GWQ
Product Code Name
Full-montage Standard Electroencephalograph
Public Device Record Key
6b30106e-fa8a-4e34-8840-44e5ab438ebe
Public Version Date
February 14, 2019
Public Version Number
4
DI Record Publish Date
September 05, 2016
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. | 290 |