Identity
- Trade Name
- Otometrics FDA UDI
- Generic Name
- Electronystagmograph FDA UDI
- Model / Reference
- Goggle face cushion kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315003295 FDA UDI
- 510(k) Number
- K122550 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
Yes
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: Electronystagmograph
Otometrics by Natus Medical Denmark ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K122550 also covers:
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- GN Otometrics A/S — Natus Medical Denmark ApS
- Otometrics — Natus Medical Denmark ApS
- Otometrics — Natus Medical Denmark ApS
- Otometrics — Natus Medical Denmark ApS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
Sources (1)
- FDA UDI 1b6261a1-939a-40d5-8b3a-2a09cabc386b 33 fields · synced Jun 1, 2026