RadioEar A/S
131 catalogue numbers from TDH39, listed by Interacoustics A/S, Denmark, under Audiometer. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
131catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Interacoustics A/S, Denmark |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-05-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature 32 to 122 °F; Storage environment temperature 0 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TDH39 | In distribution | |
| TDH39 C | In distribution | |
| DD45 S | In distribution | |
| DD45 S | In distribution | |
| DD45 | In distribution | |
| DD45 Amplivox | In distribution | |
| B-81 | In distribution | |
| B-81 | In distribution | |
| DD45 S | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| DD45 C | In distribution | |
| DD45 S | In distribution | |
| TDH39 | In distribution | |
| B71 | In distribution | |
| DD45 | In distribution | |
| B71 | In distribution | |
| B-81 | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| CIR | In distribution | |
| B71 | In distribution | |
| DD65v2 | In distribution | |
| TDH39 | In distribution | |
| TDH39 | In distribution | |
| CIR | In distribution | |
| TDH39 | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| DD45 C | In distribution | |
| DD450 | In distribution | |
| DD450 | In distribution | |
| DD65 | In distribution | |
| TDH39 | In distribution | |
| DD65v2 | In distribution | |
| DD65v2 | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| B-81 | In distribution | |
| B71 | In distribution | |
| TDH39 | In distribution | |
| B71 | In distribution | |
| DD45 | In distribution | |
| DD45 S | In distribution | |
| B71 | In distribution | |
| DD450 | In distribution | |
| DD450 | In distribution | |
| DD45 | In distribution | |
| DD45 C | In distribution | |
| DD45 C | In distribution | |
| TDH39 | In distribution | |
| TDH39 C | In distribution | |
| B71 | In distribution | |
| CIR | In distribution | |
| TDH39 Amplivox | In distribution | |
| B71 | In distribution | |
| DD45 | In distribution | |
| TDH39 | In distribution | |
| DD450 | In distribution | |
| DD45 | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| B71 | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| DD65v2 | In distribution | |
| TDH39 | In distribution | |
| DD45 Amplivox | In distribution | |
| DD45 C | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| DD45 S | In distribution | |
| B71 | In distribution | |
| DD65v2 | In distribution | |
| DD45 C | In distribution | |
| CIR | In distribution | |
| DD450 | In distribution | |
| DD65v2 | In distribution | |
| B71 | In distribution | |
| DD65 | In distribution | |
| DD65v2 | In distribution | |
| TDH39 | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| DD45 C | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| CIR | In distribution | |
| DD65v2 | In distribution | |
| B71 | In distribution | |
| TDH39 C | In distribution | |
| TDH39 | In distribution | |
| TDH39 | In distribution | |
| DD45 C | In distribution | |
| B71 | In distribution | |
| TDH39 | In distribution | |
| TDH39 | In distribution | |
| TDH39 C | In distribution | |
| TDH39 | In distribution | |
| TDH39 | In distribution | |
| DD45 | In distribution | |
| DD45 C | In distribution | |
| B-81 | In distribution | |
| B-81 | In distribution | |
| TDH39 C | In distribution | |
| TDH39 C | In distribution | |
| TDH39 | In distribution | |
| CIR | In distribution | |
| CIR | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| DD65 | In distribution | |
| B71 | In distribution | |
| B71 | In distribution | |
| TDH39 Amplivox | In distribution | |
| B71 | In distribution | |
| DD65v2 | In distribution | |
| DD45 | In distribution | |
| DD45 C | In distribution | |
| DD45 | In distribution | |
| DD45 | In distribution | |
| B-81 | In distribution | |
| DD65 | In distribution | |
| DD45 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Single Use Eartip | Etymotic Research, Inc. | 12 |
Showing 12 of 348. All products under Audiometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191372 | 2019-07-15 |
| K173567 | 2018-02-14 |
| K130795 | 2013-06-20 |
| K060883 | 2006-06-23 |
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.