Audiometer
ER3C-300 System consists of the following items: ER3C-300 Audiometric Insert Earphones, ER3C-84 7' cable with dual-mono 6.33 mm (1/4") plugs or ER3-19 Cable Shielded 300 Ohm 16' (ABR) or…
ER3C-300 System consists of the following items: ER3C-300 Audiometric Insert Earphones, ER3C-84 7′ cable with dual-mono 6.33 mm (1/4″) plugs or ER3-19 Cable Shielded 300 Ohm 16′ (ABR) or ER3-31 Shielded (ABR) Cable, or ER3-32 Shielded (ABR) Cable, ER3C-14A foam eartips (regular, 13 mm), ER3C-14B foam eartips (small, 10 mm), ER3C-14C foam eartips (large, 18 mm)
2manufacturers in China registered for this device type
73catalogue 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) | K930003 |
| Record published | 2022-02-07 |
| 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, serial number |
| Sizes | Outer diameter 3.5 to 18 mm |
| Distribution end date | 2016-12-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ER3C-300 System | In distribution | ||
| ER30 | In distribution | ||
| ER3-14D | Outer Diameter 3.5 mm | In distribution | |
| ER3-06X | 10 | In distribution | |
| ER3-14E2 | Outer Diameter 4 mm | In distribution | |
| ER13-14 | Outer Diameter 13 mm | In distribution | |
| ER10-14 | Outer Diameter 13 mm | In distribution | |
| ER10C-14C | Outer Diameter 18 mm | 18 | In distribution |
| ER10B+ Microphone | In distribution | ||
| ER3-14E-S | Outer Diameter 4 mm | In distribution | |
| ER3-04 | 10 | In distribution | |
| ER10C-14A | 25 | In distribution | |
| ER3-06X4 | 4 | In distribution | |
| ER3-06 | 2 | In distribution | |
| ER3-21-500 | In distribution | ||
| ER3-14D-S | Outer Diameter 3.5 mm | In distribution | |
| ER10C-05 | Outer Diameter 5 mm | In distribution | |
| ER10C-06 | Outer Diameter 6 mm | In distribution | |
| ER1-14A | Outer Diameter 13 mm | In distribution | |
| ER10C-14C-500 | Outer Diameter 18 mm | 500 | In distribution |
| ER1-04 | In distribution | ||
| ER10C-14A-500 | 500 | In distribution | |
| ER10C-14B-500 | Outer Diameter 10 mm | 500 | In distribution |
| ER3-06ABR | 2 | In distribution | |
| ER3-21 | In distribution | ||
| ER3-21ABR | In distribution | ||
| ER3-14A-500 | Outer Diameter 13 mm | In distribution | |
| ER1-14B-S | Outer Diameter 10 mm | In distribution | |
| ER38-14F | Outer Diameter 7 mm | In distribution | |
| ER3-14B-S | Outer Diameter 10 mm | In distribution | |
| ER3C-10 System | In distribution | ||
| ER10C-02 | Outer Diameter 3.5 mm | In distribution | |
| Shirt Clips | In distribution | ||
| ER2-21 | In distribution | ||
| ER1-14B | Outer Diameter 10 mm | In distribution | |
| ER10B-S | Outer Diameter 10 mm | In distribution | |
| ER3-14D2 | Outer Diameter 3.5 mm | In distribution | |
| ER30-17 | 2 | In distribution | |
| ER10D-KIT | In distribution | ||
| ER1-21 | In distribution | ||
| ER10C-14B-100 | Outer Diameter 10 mm | 100 | In distribution |
| ER10C-03 | Outer Diameter 3.5 mm | In distribution | |
| ER10D-TI | In distribution | ||
| ER3-14C-S | Outer Diameter 18 mm | In distribution | |
| ER3-14A MED | 50 | In distribution | |
| ER30-09 | 2 | In distribution | |
| ER1-06 | In distribution | ||
| ER1-14C | Outer Diameter 18 mm | In distribution | |
| ER13-14B | Outer Diameter 10 mm | In distribution | |
| ER003454AR | Outer Diameter 18 mm | In distribution | |
| ER3C-10 | In distribution | ||
| ER10C-14C-100 | Outer Diameter 18 mm | 100 | In distribution |
| ER10B-3 | In distribution | ||
| ER30-18 | 2 | In distribution | |
| ER3-14C | Outer Diameter 18 mm | In distribution | |
| ER10-14-S | Outer Diameter 13 mm | In distribution | |
| Sample Kit Eartips | In distribution | ||
| ER10C-14A-100 | 100 | In distribution | |
| ER3-14E | Outer Diameter 4 mm | In distribution | |
| ER3-21TR | 100 | In distribution | |
| ER10C-04 | Outer Diameter 4 mm | In distribution | |
| ER3-21TB | 4 | In distribution | |
| ER003452AR | Outer Diameter 13 mm | In distribution | |
| ER10C-14B | Outer Diameter 10 mm | 25 | In distribution |
| ER3C-50 | In distribution | ||
| ER003453AR | Outer Diameter 10 mm | In distribution | |
| ER3-14B | In distribution | ||
| ER30 System | In distribution | ||
| ER3-14A | Outer Diameter 13 mm | In distribution | |
| ER1-21ABR | In distribution | ||
| ER3C-50 System | In distribution | ||
| ER3C-300 | In distribution | ||
| ER3-60 | 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 |
| 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 |
|---|---|
| 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.