Identity
- Trade Name
- ABR Ear Cups FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Model / Reference
- ABR-CUP-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396170669 FDA UDI
- 510(k) Number
- K143395 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Evoked-potential audiometer
ABR Ear Cups by Otodynamics — 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
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- 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
K143395 also covers:
- ABR Desktop Stand/Crib Carry Crib — Otodynamics
- ABR Fixing Screw — Otodynamics
- ABR Infection Control Sleeve — Otodynamics
- ABR Starter Pack — Otodynamics
- ABR Test Cavity — Otodynamics
- Electrode Cable 1m — Otodynamics
- Electrode Cable 2m — Otodynamics
- Equipment Case for OAE+ABR Kit — Otodynamics
- Otocheck - ABR Screener — Otodynamics
- Otocheck - DPOAE + ABR Screener — Otodynamics
- Otocheck - TEOAE+ABR Screener — Otodynamics
- Otoport - ABR Screener — 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 4561679e-30de-4fd2-af6c-b66c93fb9382 33 fields · synced Jun 8, 2026