Real-EAR
Real-EAR Battery Pills (5 Sizes)
2manufacturers in China registered for this device type
26catalogue 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 | WS Audiology USA, Inc., United States |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-22 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REAL-EAR PROBE TUBE | In distribution | |
| REAL-EAR MICROPHONE | In distribution | |
| REAL-EAR 2CC COUPLER | In distribution | |
| REAL-EAR USB ISOLATION CORD | In distribution | |
| REAL-EAR INSERT TUBE W NIPPLES | In distribution | |
| REAL-EAR SOUNDBOOTH CABLE SET | In distribution | |
| REAL-EAR BTE FOAM | In distribution | |
| REAL-EAR FREE FIELD SPEAKER | In distribution | |
| REAL-EAR ITE COUPLER ATTACHMENT | In distribution | |
| REAL-EAR EAR HANGER | In distribution | |
| REAL-EAR COUPLER MICROPHONE | In distribution | |
| REAL-EAR PROBE (REFURBISHED) | In distribution | |
| REAL-EAR BATTERY PILL 312A | In distribution | |
| REAL-EAR PROBE TUBE GUIDE | In distribution | |
| REAL-EAR USB CABLE FOR PC | In distribution | |
| REAL-EAR BTE COUPLER ATTACHMENT | In distribution | |
| REAL-EAR HIT RUBBER FEET 4 PCE | In distribution | |
| REAL-EAR BATTERY PILL 13A | In distribution | |
| REAL-EAR BATTERY PILLS (5 SIZES) | In distribution | |
| REAL-EAR BATTERY PILL 5A | In distribution | |
| REAL-EAR HI-PRO EXTENSION CABLE | In distribution | |
| REAL-EAR CLIENT RESPONSE | In distribution | |
| REAL-EAR BODY COUPLER ATTACHMEN | In distribution | |
| REAL-EAR BATTERY PILL 10A | In distribution | |
| REAL-EAR DC ADAPTOR (AUD/REM) | In distribution | |
| REAL-EAR BATTERY PILL 675A | 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 |
| 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
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.