Identity
- Trade Name
- OtoNova Pro Case Service Kit FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- Case (enclosure) service kit for OtoNova Pro. Includes fascias, LED Touch circuit, switch membrane & NFC antenna (for authorised dealers/repair centers only) FDA UDI
- Model / Reference
- ON2-CASE-KIT FDA UDI
- Description
- Case (enclosure) service kit for OtoNova Pro. Includes fascias, LED Touch circuit, switch membrane & NFC antenna (for authorised dealers/repair centers only) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396173080 FDA UDI
- 510(k) Number
- K234095 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Otoacoustic emission system, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered
OtoNova Pro Case Service Kit by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K234095 also covers:
- ABR Electrode Cable (SNAP) for OtoNova Pro — Otodynamics
- ABR Electrode Cable (TAB) for OtoNova Pro — Otodynamics
- Crib/bassinet device holster for OtoNova — Otodynamics
- OtoNova Battery Assembly Service Kit — Otodynamics
- OtoNova Charger — Otodynamics
- OtoNova Pro Charger PCB Service Kit — Otodynamics
- OtoNova Pro Clinical — Otodynamics
- OtoNova Pro Clinical+AABR — Otodynamics
- OtoNova Pro Clinical+TE — Otodynamics
- OtoNova Pro Clinical+TE+AABR — Otodynamics
- OtoNova Pro Fabric Carry Case — Otodynamics
- OtoNova Pro Infection Control Sleeve — Otodynamics
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
- Otodynamics
Sources (1)
- FDA UDI fe9d7733-03b5-4607-959a-e79545ee4a6e 35 fields · synced May 30, 2026