Data / Medical devices / United Kingdom / Amplivox Ltd
Amplivox Ltd: FDA-registered device maker in Birmingham, United Kingdom, 3 510(k) clearances
Amplivox Ltd is registered with the FDA (registration 3003138182) in Birmingham, United Kingdom. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003138182
- Address
- Geneva House, International Park, Starley Way, Birmingham, United Kingdom, B37 7GN
- Owner or operator
- Amplivox Ltd (10026506)
- Roles
- Manufacturer
- First device listed
- July 23, 2008
- Registered through
- 2026
- Brand names listed
- Amplivox 116, Amplivox 170, Amplivox 240, Amplivox 260, Amplivox 270, Amplivox 270+, Amplivox CA850, Amplivox Otosure and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Manufacturer | accessdata.fda.gov |
| Tester, Auditory Impedance | ETY | 2 | Manufacturer | accessdata.fda.gov |
| Tympanometer | NAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2017 | K171265 | Otowave 302 Portable Tympanometer | NAS | Substantially Equivalent | Amplivox, Ltd. | accessdata.fda.gov |
| April 23, 2015 | K150163 | Otowave 202 Portable Tympanometer | NAS | Substantially Equivalent | Amplivox, Ltd. | accessdata.fda.gov |
| July 16, 2008 | K081841 | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | ETY | Substantially Equivalent | Amplivox, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 28, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.