Identity
- Trade Name
- Otoport Pro Clinical FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- Handheld, portable, Otoacoustic Emission [OAE] analyser for Clinical OAE hearing test applications. Includes Otoport Pro instrument, ear probe, system items, and DPOAE Clinical licence FDA UDI
- Model / Reference
- OPRO-CLN-D FDA UDI
- Description
- Handheld, portable, Otoacoustic Emission [OAE] analyser for Clinical OAE hearing test applications. Includes Otoport Pro instrument, ear probe, system items, and DPOAE Clinical licence FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396173257 FDA UDI
- 510(k) Number
- K240430 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Otoacoustic emission system, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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: Otoacoustic emission system, battery-powered
Otoport Pro Clinical by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Otodynamics
Sources (1)
- FDA UDI 510be2af-8ff1-4f7e-b62e-19a9fa8a5cc5 35 fields · synced Jun 8, 2026