Identity
- Trade Name
- OtoNova Pro Screener AABR FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app FDA UDI
- Model / Reference
- NPRO-SCR-A FDA UDI
- Description
- OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396173127 FDA UDI
- 510(k) Number
- K234095 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
OtoNova Pro Screener AABR by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
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- Ear Tip ET-12 Pack/100 pcs. — PATH medical GmbH · Class II
- Insert Earphone PIEP monaural — PATH medical GmbH · Class II
- QScreen Set — PATH medical GmbH · Class II
- Ear Tip ET-S11 Pack/100 pcs. — PATH medical GmbH · Class II
- Sentiero Desktop AuDX PRO FLEX — PATH medical GmbH · Class II
- Sentiero Diagnostic — PATH medical GmbH · Class II
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 Fabric Carry Case — 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 |
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Manufacturer
- Manufacturer
- Otodynamics
Sources (1)
- FDA UDI 11c9cf22-d0e1-412c-b171-453d03c7c663 35 fields · synced May 31, 2026