Data / Medical devices / Germany / It Concepts GMBH
It Concepts GMBH: FDA-registered device maker in Lahnau Hesse, Germany, 1 510(k) clearance
It Concepts GMBH is registered with the FDA (registration 3009118476) in Lahnau Hesse, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 23, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009118476
- Address
- Gewerbestrasse 17 IT Concepts GmbH, Lahnau Hesse, Germany, 35633
- Owner or operator
- IT Concepts GmbH (10058477)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 4, 2018
- Registered through
- 2026
- Brand names listed
- Laryngoscope, nasopharyngoscope, Otoscope OX2, Spiro-VISTA, VIOT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laryngoscope, Nasopharyngoscope | EQN | 2 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Contract 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 23, 2015 | K150248 | ORL Video NasoPharyngo-Larngoscope | EQN | Substantially Equivalent | Jedmed Instrument Company | accessdata.fda.gov |
Compare with other makers
- All makers of Laryngoscope, Nasopharyngoscope
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Otoscope
Updated July 23, 2015. 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.