Identity
- Trade Name
- Diopsys® FDA UDI
- Generic Name
- Vision electrophysiology analysis system FDA UDI
- Device Name
- NOVA Software FDA UDI
- Model / Reference
- NOVA 2.19 FDA UDI
- Description
- NOVA Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850514007091 FDA UDI
- 510(k) Number
- K101763 FDA UDI
- FDA Product Code
- GWE FDA UDI
- GMDN Term
- Vision electrophysiology analysis system 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vision electrophysiology analysis system
Diopsys® by Diopsys, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vision electrophysiology analysis system.
- Diopsys® — Diopsys, Inc. · Class II
- Diopsys® — Diopsys, Inc. · Class II
- Diopsys® — Diopsys, Inc. · Class II
- Diopsys® — Diopsys, Inc. · Class II
- Diopsys® — Diopsys, Inc. · Class II
- Diopsys® — Diopsys, Inc. · Class II
- Diopsys® — Diopsys, Inc. · Class II
- Diopsys® — Diopsys, Inc. · Class II
Cleared under the same submission
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
- Diopsys, Inc.
Sources (1)
- FDA UDI 8a5b0992-e7bb-4f0f-b8a8-ce643a870827 34 fields · synced May 30, 2026