Duns Number:856998166
Device Description: software for acquisition, review, storage , process and measure of biologic signals (parti software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG)
Catalog Number
-
Brand Name
Micromed
Version/Model Number
BRAIN QUICK SOFTWARE
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
K000963
Product Code
GWE
Product Code Name
Stimulator, Photic, Evoked Response
Public Device Record Key
ec443bc5-582b-4ee2-8eea-fe82666e58f5
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
May 21, 2018
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. | 12 |