Sanibel Supply A/S
DD450 High Frequency Headset CH 30° 6.3mm x2 2Poles WITH MEMORY + Mini 4Pins male connector
2manufacturers in China registered for this device type
18catalogue 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 |
| 510(k) | K930553 |
| Record published | 2025-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-08-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Foam ear tip 13 mm, ER1/ER2 | 50 | In distribution | |
| Foam ear tip 13 mm, ER10B+ | 50 | In distribution | |
| DD450 High Frequency Headset CH | In distribution | ||
| Foam ear tip 13 mm, ER10C | 25 | In distribution | |
| Foam ear tip 13 mm, ER10C | 500 | In distribution | |
| Foam ear tip 10 mm, ER1/ER2 | 10 | In distribution | |
| DD450 High Frequency Headset CH | In distribution | ||
| ER10C-03 | 20 | In distribution | |
| Foam ear tip 10 mm, ER1/ER2 | 50 | In distribution | |
| Foam ear tip 10 mm, ER10C | 500 | In distribution | |
| Foam ear tip 18 mm, ER10C | 18 | In distribution | |
| DD450 High Frequency Headset CH | In distribution | ||
| DD450 High Frequency Headset CH | In distribution | ||
| DD450 High Frequency Headset CH | In distribution | ||
| DD450 High Frequency Headset CH | In distribution | ||
| ER10C-04 | 20 | Withdrawn | |
| ER10C-06 | 20 | Withdrawn | |
| ER10C-05 | 20 | Withdrawn |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 |
| 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.