Identity
- Trade Name
- ENGplus™ FDA UDI
- Generic Name
- Electronystagmograph FDA UDI
- Model / Reference
- EV2000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B435ENGEV2000 FDA UDI
- 510(k) Number
- K010059 FDA UDI
- FDA Product Code
- GWN FDA UDI
- GMDN Term
- Electronystagmograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1460 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: Electronystagmograph
ENGplus™ by Western Systems Research Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K010059 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
- Western Systems Research Inc.
Sources (1)
- FDA UDI 92dd21c6-9be1-443b-a959-6a6adada40a4 33 fields · synced May 30, 2026