QScreen Set
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 100306 Headphone DD45 HP-06 or 101044 Headphone…
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD65 v2 P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100110-QScreen FW DPOAE P/N 100536-QScreen FW FMDPOAE P/N 100109-QScreen FW TEOAE P/N 100414-QScreen FW Labelprinter P/N 101043 Accessory box EP-LT (AB-LT01) P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual English
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Dong Guan Danchen Electrical Products Ltd. | Dong Guan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Path, Germany |
|---|---|
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Manufacturer |
| 510(k) | K220139 |
| Record published | 2023-05-19 |
| Record revised | 2024-09-18 (version 3) |
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 number | Size | Status |
|---|---|---|
| 101275-T-A-EP | In distribution | |
| 101275-D | In distribution | |
| 101275-T-A-ECC | In distribution | |
| 101275-T-D-A-ECC | In distribution | |
| 101275-T-D-A-HP | In distribution | |
| 101275-A-IP | In distribution | |
| 101275-A-HP | In distribution | |
| 101275-D-A-EP | In distribution | |
| 101275-T-D-A-EP | In distribution | |
| 101275-D-A-IP | In distribution | |
| 101275-AS-HP | In distribution | |
| 101275-AS-IP | In distribution | |
| 101275 | In distribution | |
| 101275-AS-ECC | In distribution | |
| 101275-A-EP | In distribution | |
| 101275-T-A-HP | In distribution | |
| 101275-T | In distribution | |
| 101275-T-D | In distribution | |
| 101275-AS-EP | In distribution | |
| 101275-T-A-IP | In distribution | |
| 101275-A-ECC | In distribution | |
| 101275-D-A-ECC | In distribution | |
| 101275-T-D-A-IP | In distribution | |
| 101275-D-A-HP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 117 |
| Natus Medical | Natus Medical Incorporated | 25 |
| AccuScreen | Natus Medical Denmark ApS | 20 |
| Natus | Natus Medical Incorporated | 18 |
| Sentiero Advanced | Path | 14 |
| Algo Pro | Natus Medical Denmark ApS | 9 |
| Algo Pro | Xltek | 9 |
| Stimulator, Auditory, Evoked Response | Medtronic Xomed, Inc. | 7 |
| Algo 3i | Natus Medical Denmark ApS | 5 |
| Teoae probe tips | Otodynamics, Ltd. | 5 |
| Algo 5 | Natus Medical Denmark ApS | 5 |
| ICS | Natus Medical Denmark ApS | 5 |
Showing 12 of 305. All products under Stimulator, Auditory, Evoked Response
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220139 | 2022-08-03 |
| K211147 | 2021-10-14 |
| K131141 | 2013-06-27 |
| K100661 | 2010-07-01 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason |
|---|---|---|---|
| 2025-11-06 | Class II | Component change control | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses |
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.