Identity
- Trade Name
- Espion FDA UDI
- Generic Name
- Electroretinograph FDA UDI
- Device Name
- E3 System; with ColorBurst 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: D315-1-1-NNNNN-NN-2-N FDA UDI
- Model / Reference
- D315 FDA UDI
- Description
- E3 System; with ColorBurst 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: D315-1-1-NNNNN-NN-2-N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850594007141 FDA UDI
- 510(k) Number
- K863956 FDA UDI
- FDA Product Code
- GWE FDA UDI
- GMDN Term
- Electroretinograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroretinograph
Espion by Diagnosys Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K863956 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnosys Llc
Sources (1)
- FDA UDI edd8d5d3-d4c5-4bc5-aa87-63b1e8a90d0d 35 fields · synced May 30, 2026