Duns Number:856998166
Device Description: LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the EEG recording. The patient’s retina is stimulated with bright light flashes in order to stimulate brain activity changes. These changes can be used to evaluate brain functioning.The stimulation methods, like the photic stimulation, are integral part of the EEG exams.
Catalog Number
-
Brand Name
Micromed
Version/Model Number
LED PHOTIC
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
K211974
Product Code
GWE
Product Code Name
Stimulator, Photic, Evoked Response
Public Device Record Key
0eb7e058-3f83-44c8-a2c1-41a6e272bb37
Public Version Date
November 02, 2021
Public Version Number
1
DI Record Publish Date
October 25, 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. | 12 |