Oscilla
Audiometer w. H210A headset & BC-2 Bone Conductor
2manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | Oscilla A/S, Denmark |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Oscilla® A30 w. H210A headset | In distribution | |
| Oscilla® A60 w. H210 headset & B71 Bone C. | In distribution | |
| Oscilla® A50 w. H210A headset & BC-2 Bone C. | In distribution | |
| Oscilla® A30 w. DD65 headset | In distribution | |
| Oscilla® A50 w. H210 headset & B71 Bone C. | In distribution | |
| Oscilla® A60 w. H210A headset & BC-2 Bone C. | In distribution |
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 |
| 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
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.