Who else makes this device?

Name: Sentiero Diagnostic
Brand: Sentiero Diagnostic

Ear Nose & Throat › DiagnosticAudiometer

Sentiero Diagnostic

Sentiero Diagnostic OAE Audiometrie Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Diagnostic device with touchscreen AN100098 5. Probe…

Registry build 21.09.26

Sentiero Diagnostic OAE Audiometrie Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Diagnostic device with touchscreen AN100098 5. Probe EP-DP Path long AN100028-US 6. Headphone HB7 / DD-45 AN100306-US 7. DPOAE Software AN100110 8. PTA class 3 Software AN100114 9. TEOAE Software AN100109 10. DPOAE Threshold Estimation Software AN100111 11. DPHiRES Software AN100537 12. FMDPOAE Software AN100536 13. 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 14. Software label printer AN100414 15. Accessory box Sentiero Combo AN100261 16. Power supply Sentiero AN101013+AN100993-USA

2manufacturers in China registered for this device type

4catalogue 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 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	2016-08-31
Record revised	2020-06-24 (version 4)

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 Diagnostic
Catalogue number	Size	Status
100250-US2		In distribution
100250-US4		In distribution
100250-US3		In distribution
100250-US2-T		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 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.