Duns Number:131488467
Device Description: Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-1-CDXR-2-X
Catalog Number
-
Brand Name
Espion
Version/Model Number
D310
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K863956
Product Code
GWE
Product Code Name
Stimulator, Photic, Evoked Response
Public Device Record Key
168479eb-a6ad-4312-bcfe-bb38b7ff5c94
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 15, 2017
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. | 132 |