Identity
- Trade Name
- Bio-Logic AudX FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in the earcanal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear as a result of normal peripheral hearing processes. The AuDX Pro device performs both transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments. FDA UDI
- Model / Reference
- 580-AXPBOX-018 FDA UDI
- Description
- The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in the earcanal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear as a result of normal peripheral hearing processes. The AuDX Pro device performs both transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments. FDA UDI
Identifiers
- Catalog Number
- 580-AXPBOX-018 FDA UDI
- Primary DI / UDI-DI
- 00382830054980 FDA UDI
- 510(k) Number
- K111618 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Evoked-potential audiometer 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
Yes
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
No
FDA UDI
Category: Evoked-potential audiometer
Bio-Logic AudX by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
- ECochG Adapters — Vivosonic Inc · Class II
- Ear Tip PM014H Pack/100 pcs. — PATH medical GmbH · Class II
- 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
- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
Cleared under the same submission
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
- Natus Medical Incorporated
Sources (1)
- FDA UDI 4db4a646-756e-4ba0-9e1d-fb33db3fb87a 37 fields · synced Jun 8, 2026