Welch Allyn, Inc.
Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit -- 3 mm to 15 mm sizes (#39420), Calibration…
Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit — 3 mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100-240 V, 50-60 Hz AC, Lithium-Ion Integrated Battery; IEC Plug Type-B, -C, -G, and -I
Who Else Makes It
All of them in Zhejiang.
| 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
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-08-28 |
| Record revised | 2025-02-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901001 | In distribution | |
| 901001 | In distribution | |
| 901035 | In distribution | |
| 901001 | In distribution | |
| 901001 | In distribution | |
| 901031 | In distribution | |
| 901001 | In distribution | |
| 901035 | In distribution | |
| 901031 | In distribution | |
| 901035 | In distribution | |
| 901031 | In distribution | |
| 901035 | In distribution | |
| 901001 | In distribution | |
| 901122 | In distribution | |
| 901001 | In distribution | |
| 901035 | In distribution | |
| 901035 | In distribution | |
| 901122 | In distribution | |
| 901001 | In distribution | |
| 901001 | In distribution | |
| 901031 | In distribution | |
| 901031 | In distribution | |
| 901035 | In distribution | |
| 901001 | In distribution | |
| 901035 | In distribution | |
| 901031 | Withdrawn | |
| 901031 | Withdrawn | |
| 901035 | Withdrawn | |
| 901031 | Withdrawn |
Same 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 |
| 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 |
| Single Use Eartip | Etymotic Research, Inc. | 12 |
Showing 12 of 348. All products under Audiometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K884218 | 1989-03-10 |
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.