Sentiero Desktop Diagnostic
Basic Information
- Brand Name
- Sentiero Desktop Diagnostic
- Primary DI
- 04260223141553
- Version / Model
- 100497-US9
- Company Name
- PATH medical GmbH
- Labeler DUNS
- 551540334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 7
- Public Version Date
- 2022-09-29
- Public Version Status
- Update
- Public Device Record Key
- fa3ac108-dcd8-4afb-ba21-b45930df95f4
Device Description
Sentiero Desktop Diagnostic Set US9 Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Threshold estimation software, Simultaneous DPOAE measurements on both ears (two probes incl.) Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. DD45 HB7 headphone (calibrated) AN100306-US 6. Bone conductor B81 (calibrated) AN100888 or B71W optionally. 7. Gooseneck microphone AN100779 8. FW Reflex & Tymp class1 AN100561 9. Software label printer AN100414 10. Label printer cable Senti / Sentiero desktop AN100417 11. DPOAE Software AN100110 12. TEOAE Software AN100109 13. DPHiRES Software AN100537 14. FMDPOAE Software AN100536 15. DPOAE Threshold Estimation Software AN100111 16. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 17. FW Live AN100825 18. UT-08 Spondee Words for Children (English) AN100819 19. UT-10 Spondee Words for Adults (English) AN100821 20. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 21. UT-12 Central Institute for the Deaf W22 AN100823 22. UT-13 PBK-50 (English) AN100824 23. Accessory box for Tymp probe AN100587 24. Accessory box AB08 AN100734-P 25. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 26. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 27. Test cavity tymp AN100549 28. PTA Class 3 Software AN100114
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | Neurology | 882.1900 | 2 |
| ETY | Tester, Auditory Impedance | Ear, Nose, Throat | 874.1090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35747 | Evoked-potential audiometer | An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260223141553 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133012 | 000 |