Identity
- Trade Name
- Sentiero Advanced NavPRO One Set FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- content: - carrying bag A/N100503 - USB cable A/N100089 - ABR electrodes A/N100468 - NavPRO One A/N100360-NPO - Electrode trunk cable A/N100881 - electrode lead cable A/N100891-1 - Heaphone HB7/DD45 A/N100306-US - Probe EP-DP PATH long A/N100028-US - Bone Conductor B71 A/N100344 - Gooseneck Microphone A/N100779 - FW ABR 100337 - FW eABR A/N100929 - FW ASSR A/N100465 - FW ECochG A/N100464 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMPDOAE A/N100536 - FW DPHiRES A/N100537 - FW PTA3 A/N 100114 - FW High Frequency A/N100454 - FW Magic A/N100112 - FW Labelprinter A/N100414 - FW Mira PC- Software A/N100116 - Accessory Box Combo A/N100261 - Power Supply US Sentiero Advanced A/N100268-US - User Manual A/N100904-EN-BL FDA UDI
- Model / Reference
- 100340-BLP1 FDA UDI
- Description
- content: - carrying bag A/N100503 - USB cable A/N100089 - ABR electrodes A/N100468 - NavPRO One A/N100360-NPO - Electrode trunk cable A/N100881 - electrode lead cable A/N100891-1 - Heaphone HB7/DD45 A/N100306-US - Probe EP-DP PATH long A/N100028-US - Bone Conductor B71 A/N100344 - Gooseneck Microphone A/N100779 - FW ABR 100337 - FW eABR A/N100929 - FW ASSR A/N100465 - FW ECochG A/N100464 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMPDOAE A/N100536 - FW DPHiRES A/N100537 - FW PTA3 A/N 100114 - FW High Frequency A/N100454 - FW Magic A/N100112 - FW Labelprinter A/N100414 - FW Mira PC- Software A/N100116 - Accessory Box Combo A/N100261 - Power Supply US Sentiero Advanced A/N100268-US - User Manual A/N100904-EN-BL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143366 FDA UDI
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- GWJ FDA UDIEWO FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 FDA UDI874.1050 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 Advanced NavPRO One 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 453b89cc-590f-48f2-8215-fd8163654e5f 35 fields · synced May 29, 2026