Identity
- Trade Name
- Sentiero Basic AuDX PRO Set FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Basic Set for AuDX PRO branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX PRO A/N100098-AUP - Headphone HDA300 A/N100630 - Probe EP-DP PATH long A/N100028-US - Gooseneck microphone A/N 100779 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMDPOAE A/N100536 - FW DPHiRES A/N 100537 - FW PTA Class 3 A/N100114 - FW High frequency A/N100454 - FW Magic A/N100112 - Speech material Spondees child A/N100463-UT08 - Speech material Spondees adult A/N100463-UT10 - Speech material NU-6 A/N100463-UT11 - Speech material CID W-22 A/N100463-UT12 - Speech material PBK-50 A/N100463-UT13 - Speech material Maryland CNC A/N100463-UT15 - FW Live A/N100825 - FW Mira PC- Software A/N100116 - FW Labelprinter A/N100414 - Accessory box combo A/N100261 - Power Supply Sentiero US A/N100083-US - User Manual A/N100904-EN-BL FDA UDI
- Model / Reference
- 100250-BLP1 FDA UDI
- Description
- Basic Set for AuDX PRO branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX PRO A/N100098-AUP - Headphone HDA300 A/N100630 - Probe EP-DP PATH long A/N100028-US - Gooseneck microphone A/N 100779 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMDPOAE A/N100536 - FW DPHiRES A/N 100537 - FW PTA Class 3 A/N100114 - FW High frequency A/N100454 - FW Magic A/N100112 - Speech material Spondees child A/N100463-UT08 - Speech material Spondees adult A/N100463-UT10 - Speech material NU-6 A/N100463-UT11 - Speech material CID W-22 A/N100463-UT12 - Speech material PBK-50 A/N100463-UT13 - Speech material Maryland CNC A/N100463-UT15 - FW Live A/N100825 - FW Mira PC- Software A/N100116 - FW Labelprinter A/N100414 - Accessory box combo A/N100261 - Power Supply Sentiero US A/N100083-US - User Manual A/N100904-EN-BL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143342 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Sentiero Basic AuDX PRO Set by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K133012 also covers:
- AuDX Device with touchscreen — PATH medical GmbH
- AuDX PRO FLEX Device with touchscreen — PATH medical GmbH
- Bone Conductor B71W — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Ear Coupler Cable — PATH medical GmbH
- Ear Coupler Cable — PATH medical GmbH
- Ear Coupler Set — PATH medical GmbH
- Ear Tip IT-02 Pack/100 pcs. — PATH medical GmbH
- Ear Tip IT-03 Pack/100 pcs. — PATH medical GmbH
- Headphone DD-45 contra — PATH medical GmbH
- Headphone DD-65 — PATH medical GmbH
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
- PATH medical GmbH
Sources (1)
- FDA UDI d3a0750d-633e-4fff-980c-9c4009889df8 35 fields · synced May 29, 2026