Single Use Eartip
9mm Single Use Ear tip 100pk
2manufacturers in China registered for this device type
12catalogue numbers in this listing
8510(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 | Etymotic Research, Inc., United States |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K930553 |
| Record published | 2016-09-20 |
| Record revised | 2025-06-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 3 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ER10D-T03 | Outer Diameter 3 mm | In distribution |
| ER10D-T04 | Outer Diameter 4 mm | In distribution |
| ER10D-T09 | Outer Diameter 9 mm | In distribution |
| ER10D-T16 | Outer Diameter 16 mm | In distribution |
| ER10D-T05 | Outer Diameter 5 mm | In distribution |
| ER10D-T08 | Outer Diameter 8 mm | In distribution |
| ER10D-T14 | Outer Diameter 14 mm | In distribution |
| ER10-T06 | Outer Diameter 6 mm | In distribution |
| ER10D-T11 | Outer Diameter 11 mm | In distribution |
| ER10D-T13 | Outer Diameter 13 mm | In distribution |
| ER10D-T12 | Outer Diameter 12 mm | In distribution |
| ER10D-T07 | Outer Diameter 7 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150491 | 2015-03-26 |
| K112733 | 2011-12-16 |
| K070880 | 2007-06-07 |
| K011114 | 2001-07-03 |
| K010165 | 2001-03-12 |
| K980533 | 1998-03-23 |
| K930553 | 1993-09-29 |
| K930003 | 1993-06-18 |
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.