Data / Medical devices / Tester, Auditory Impedance
Tester, Auditory Impedance (ETY): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Tester, Auditory Impedance (product code ETY, Class 2, 21 CFR 874.1090). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 70 510(k) clearances under this code, the latest on March 6, 2019, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ETY
- Device class
- 2
- Regulation
- 874.1090
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| Denmark | 3 |
| United States | 2 |
| Germany | 2 |
| Ireland | 2 |
| United Kingdom | 1 |
| Italy | 1 |
| Poland | 1 |
Makers of Tester, Auditory Impedance
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Group LLC | Eden Prairie, MN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 11 | July 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| Interacoustics A/S | Middelfart Syddanmark, Denmark | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 5 | July 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| MAICO Diagnostics GmbH | Berlin, Germany | Complaint file establishment, Manufacturer, Specification developer | 2 | November 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Natus Medical Denmark ApS | TAASTRUP Hovedstaden, Denmark | Complaint file establishment, Manufacturer, Specification developer | 2 | September 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| Amplivox Ltd | Birmingham, United Kingdom | Manufacturer | 1 | July 16, 2008 | 0 | 0 | 0 | api.fda.gov |
| Asicomo A/S | Rodby Sjaelland, Denmark | Manufacturer | 1 | March 31, 2004 | 0 | 0 | 0 | api.fda.gov |
| M.R.S. SRL | Gazzaniga Bergamo, Italy | Manufacturer | 1 | July 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer | 1 | June 10, 1986 | 0 | 0 | 0 | api.fda.gov |
| DGS Diagnostics Sp. z o.o | Kolbaskowo Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Manufacturing Limited | GORT, Co. Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Sensory Ireland Ltd | Gort Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Path | Germering Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 6, 2019. 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.