Oscilla
12 catalogue numbers from SM950, listed by Inmedico A/S, under Audiometer. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
12catalogue 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 | Inmedico A/S |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2023-08-03 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 50 °C; Storage environment atmospheric pressure 50 to 120 KiloPascal; Handling environment temperature 15 to 35 °C; Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 80 to 120 KiloPascal |
| Distribution end date | 2018-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM950 | Withdrawn | |
| USB350-SP | Withdrawn | |
| USB310 | Withdrawn | |
| USB330 | Withdrawn | |
| SM450-FF | Withdrawn | |
| SM950-S | Withdrawn | |
| SM960-C | Withdrawn | |
| SM920-P | Withdrawn | |
| USB350-B | Withdrawn | |
| SM910-B | Withdrawn | |
| SM930 | Withdrawn | |
| SM910 | Withdrawn |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 |
| 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 |
| Single Use Eartip | Etymotic Research, Inc. | 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.