Identity
- Trade Name
- Speech & Bone Kit Sentiero Desktop FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Content: 1. Bone conductor calibrated (Sentiero Advanced / Sentiero desktop, Senti desktop flex) AN100888 2. Gooseneck microphone AN100779 3. FW Live AN100825 4. UT-08 Spondee Words for Children (English) AN100819 5. UT-10 Spondee Words for Adults (English) AN100821 6. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 7. UT-12 Central Institute for the Deaf Auditory Test W22 (English) AN100823 8. UT-13 PBK-50 (English) AN100824 FDA UDI
- Model / Reference
- 100780-D FDA UDI
- Description
- Content: 1. Bone conductor calibrated (Sentiero Advanced / Sentiero desktop, Senti desktop flex) AN100888 2. Gooseneck microphone AN100779 3. FW Live AN100825 4. UT-08 Spondee Words for Children (English) AN100819 5. UT-10 Spondee Words for Adults (English) AN100821 6. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 7. UT-12 Central Institute for the Deaf Auditory Test W22 (English) AN100823 8. UT-13 PBK-50 (English) AN100824 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141737 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
- 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
Category: Evoked-potential audiometer
Speech & Bone Kit Sentiero Desktop by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Evoked-potential audiometer.
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- Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
- ABR Test Cavity — Otodynamics · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 86e731a7-408c-4d1d-8a6f-fca67bef612b 34 fields · synced May 30, 2026