Identity
- Trade Name
- OtoNova Pro Fabric Carry Case FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- Lightweight carry case for the OtoNova Pro kit, with sections for OtoNova Pro, charger, wireless charging pad, probes, probe tips box and test cavity. Handy compartments inside and outside for documentation and pens. Detachable shoulder strap. Dimensions: 325mm x 265mm x 100mm FDA UDI
- Model / Reference
- NPRO-CAS FDA UDI
- Description
- Lightweight carry case for the OtoNova Pro kit, with sections for OtoNova Pro, charger, wireless charging pad, probes, probe tips box and test cavity. Handy compartments inside and outside for documentation and pens. Detachable shoulder strap. Dimensions: 325mm x 265mm x 100mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396173738 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
No
FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered
OtoNova Pro Fabric Carry Case 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 Case Service Kit — 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 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 897cf703-5c4b-45b5-9e0f-8463e2803bf6 35 fields · synced May 30, 2026