Duns Number:538025107
Device Description: A non-magnetic 128-channel EEG cap (size 52-58 cm) with sintered Ag/AgCl electrodes
Catalog Number
NM23895N
Brand Name
128-channel EEG cap (M)
Version/Model Number
NM24304N
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
-
Product Code
OLY
Product Code Name
Magnetoencephalograph
Public Device Record Key
f6b8ef46-1f53-4d76-93bd-0e6137c1859b
Public Version Date
May 13, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
06430056480251
Quantity per Package
1
Contains DI Package
06430056480176
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |