Who else makes this device?

Name: Sentiero Desktop Diagnostic
Brand: Sentiero Desktop Diagnostic

Ear Nose & Throat › DiagnosticAudiometer

Sentiero Desktop Diagnostic

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:…

Registry build 21.09.26

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

2manufacturers in China registered for this device type

10catalogue numbers in this listing

2510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

All of them in Zhejiang.

Chinese manufacturers registered for FDA product code EWO
Manufacturer	City	Province	Registered as	Device types
Fastsound Acoustic Technology (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	6
Zoomax Technology Co., Limited	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Sentiero Desktop Diagnostic
Listed by	Path, Germany
FDA product code	EWO
Device type	Audiometer
Device class	Class 2
Regulation	21 CFR 874.1050
Establishment	Manufacturer
510(k)	K133012
Record published	2018-03-31
Record revised	2022-09-29 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Sentiero Desktop Diagnostic
Catalogue number	Size	Status
100497-US12		In distribution
100497-US13		In distribution
100497-US6		In distribution
100497-SK		In distribution
100497-US7		In distribution
100497		In distribution
100497-US8		In distribution
100497-US9		In distribution
100497-ED		In distribution
100497-US11		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
RadioEar A/S	Interacoustics A/S	131
GN Otometrics A/S	Natus Medical Denmark ApS	88
Audiometer	Etymotic Research, Inc.	73
Siemens	WS Audiology USA, Inc.	57
Bio-logic	Natus Medical Incorporated	33
Welch Allyn, Inc.	Welch Allyn, Inc.	29
Real-EAR	WS Audiology USA, Inc.	26
Sanibel Supply A/S	Interacoustics A/S	18
Natus	Natus Medical Incorporated	14
Grason-Stadler	Diagnostic Group LLC	12
Interacoustics	Interacoustics A/S	12
Oscilla	Inmedico A/S	12

Showing 12 of 348. All products under Audiometer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K213345	2022-06-22
K133012	2014-06-09

Recalls Naming This Product

4 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Sentiero Desktop Diagnostic
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Path	510(k) number	2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	15 units
Path	510(k) number	2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	28 units
Path	510(k) number	2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	23 units
Path	510(k) number	2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	1 unit

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.