Who else makes this device?

Name: Sentiero Basic AuDX PRO Set
Brand: Sentiero Basic AuDX PRO Set

Ear Nose & Throat › DiagnosticAudiometer

Sentiero Basic AuDX PRO Set

Basic Set for AuDX PRO branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX PRO A/N100098-AUP - Headphone HDA300 A/N100630 - Probe EP-DP PATH long A/N100028-US -…

Registry build 21.09.26

Basic Set for AuDX PRO branded Sentiero Content: – carrying bag A/N100503 – USB cable A/N100089 – AuDX PRO A/N100098-AUP – Headphone HDA300 A/N100630 – Probe EP-DP PATH long A/N100028-US – Gooseneck microphone A/N 100779 – FW TEOAE A/N100109 – FW DPOAE A/N100110 – FW FMDPOAE A/N100536 – FW DPHiRES A/N 100537 – FW PTA Class 3 A/N100114 – FW High frequency A/N100454 – FW Magic A/N100112 – Speech material Spondees child A/N100463-UT08 – Speech material Spondees adult A/N100463-UT10 – Speech material NU-6 A/N100463-UT11 – Speech material CID W-22 A/N100463-UT12 – Speech material PBK-50 A/N100463-UT13 – Speech material Maryland CNC A/N100463-UT15 – FW Live A/N100825 – FW Mira PC- Software A/N100116 – FW Labelprinter A/N100414 – Accessory box combo A/N100261 – Power Supply Sentiero US A/N100083-US – User Manual A/N100904-EN-BL

2manufacturers in China registered for this device type

1catalogue number

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 Basic AuDX PRO Set
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	2018-04-10
Record revised	2020-06-30 (version 3)

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
Distribution end date	2020-06-29

Catalogue Numbers

Catalogue numbers for Sentiero Basic AuDX PRO Set
Catalogue number	Size	Status
100250-BLP1		Withdrawn

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 Basic AuDX PRO Set
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.