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Patient Response Button
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 100169Ref 100343
Identity
- Trade Name
- Patient button EUDAMEDPatient Response Button FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Live Speech Microphone EUDAMEDPatient response button for Sentiero Advanced FDA UDIPatient response button for Sentiero FDA UDI
- Model / Reference
- 100343 EUDAMEDFDA UDI100169 EUDAMEDFDA UDI
- Description
- Patient response button for Sentiero Advanced FDA UDIPatient response button for Sentiero FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223140877 EUDAMEDFDA UDI04260223140860 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022Sentiero-199 EUDAMED
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- GWJ FDA UDIEWO FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI874.1050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
Patient Response Button by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
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- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (4)
- FDA UDI 005e1b7e-d776-412c-99fe-2767ac1d5122 34 fields · synced Jul 24, 2026
- FDA UDI 073c0364-d6c9-450f-b4eb-0b3d091e2819 34 fields · synced May 30, 2026
- EUDAMED 60bd829a-7f24-456b-9d92-19374906aaf3 61 fields · synced Jul 10, 2026
- EUDAMED faacf0fd-5950-412b-9a59-934ff2f275a1 61 fields · synced Jul 24, 2026