Identity
- Trade Name
- XPD Ear Probe FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- Next generation 'X-series' general purpose ear probe for TEOAE and DPOAE hearing screening/analysis, auditory stimulus for AABR; 1.2 metre cable, 14-pin push/pull plug. For use with Otoport Pro and OtoNova Pro OAE and OAE+AABR instruments. FDA UDI
- Model / Reference
- PR-XPD FDA UDI
- Description
- Next generation 'X-series' general purpose ear probe for TEOAE and DPOAE hearing screening/analysis, auditory stimulus for AABR; 1.2 metre cable, 14-pin push/pull plug. For use with Otoport Pro and OtoNova Pro OAE and OAE+AABR instruments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396172243 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered
XPD Ear Probe by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otoacoustic emission system, battery-powered.
- ECochG Adapters — Vivosonic Inc · Class II
- Integrity OAE Probe — Vivosonic Inc · Class II
- Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II
- Interacoustics — Interacoustics A/S · Class II
- Lucid Hearing ® — ETYMOTIC RESEARCH, INC. · Class II
- Maico — MAICO Diagnostics GmbH · Class II
- Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II
- Etymotic Research — ETYMOTIC RESEARCH, INC. · 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
K240430 also covers:
- ABR Electrode Cable V2 (NHSP) for Otoport V2/Pro — Otodynamics
- ABR Electrode Cable V2 (SNAP) for Otoport V2/Pro — Otodynamics
- ABR Electrode Cable V2 (TAB) for Otoport V2/Pro — Otodynamics
- Otoport Charger V2 — Otodynamics
- Otoport Mini Printer V2 package — Otodynamics
- Otoport Pro AABR instrument — Otodynamics
- Otoport Pro Advanced Clinical — Otodynamics
- Otoport Pro Advanced Clinical+AABR — Otodynamics
- Otoport Pro Analogue Front End PCB Service Kit — Otodynamics
- Otoport Pro Barcode Module & Flexi service kit — Otodynamics
- Otoport Pro Battery Assembly Service Kit — Otodynamics
- Otoport Pro Case service kit — 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 158bbd0d-69b7-4468-a4e8-1bdfb509efee 35 fields · synced Jun 8, 2026