Data / Medical devices / Germany / MAICO Diagnostics GmbH
MAICO Diagnostics GmbH: FDA-registered device maker in Berlin, Germany, 8 510(k) clearances
MAICO Diagnostics GmbH is registered with the FDA (registration 3002504821) in Berlin, Germany. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 29, 2017. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3002504821
- Address
- Sickingenstr. 70-71, Berlin, Germany, 10553
- Owner or operator
- DEMANT A/S (8010048)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 21, 1994
- Registered through
- 2026
- Brand names listed
- AC33, AC40, AD226, AD229, AD528, AD629, AM282, AS608 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tester, Auditory Impedance | ETY | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 29, 2017 | K171506 | Easyscreen | EWO | Substantially Equivalent | Maico Diagnostics GmbH | accessdata.fda.gov |
| November 16, 2016 | K162210 | touchTymp | ETY | Substantially Equivalent | Maico Diagnostics GmbH | accessdata.fda.gov |
| March 26, 2015 | K150491 | ER36 Series OAE Test System | EWO | Substantially Equivalent | Etymotic Research, Inc. | accessdata.fda.gov |
| September 10, 2013 | K123896 | CCS-200 SPIROMETER | BZG | Substantially Equivalent | Benson Medical Instruments Co. | accessdata.fda.gov |
| April 9, 2009 | K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE | ETY | Substantially Equivalent | Interacoustics AS | accessdata.fda.gov |
| January 29, 2009 | K082035 | MAICO MB 11 WITH BERAPHONE PROBE | GWJ | Substantially Equivalent | Maico Diagnostics | accessdata.fda.gov |
| June 23, 2006 | K060883 | PILOT TEST OR DETECTIVE AUDIOMETERS | EWO | Substantially Equivalent | Interacoustics A/S | accessdata.fda.gov |
| August 24, 2001 | K011746 | MB 11 | GWJ | Substantially Equivalent | Maico Diagnostic GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Spirometer, Diagnostic
- All makers of Tester, Auditory Impedance
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Audiometer
Updated August 29, 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.