Data / Medical devices / Austria / CNSYSTEMS MEDIZINTECHNIK GmbH
CNSYSTEMS MEDIZINTECHNIK GmbH: FDA-registered device maker in Graz Steiermark, Austria, 4 510(k) clearances
CNSYSTEMS MEDIZINTECHNIK GmbH is registered with the FDA (registration 3006113127) in Graz Steiermark, Austria. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006113127
- Address
- Reininghausstrasse 13, Graz Steiermark, Austria, A-8020
- Owner or operator
- CNSystems Medizintechnik GmbH (9088754)
- Roles
- Manufacturer
- First device listed
- June 19, 2006
- Registered through
- 2026
- Brand names listed
- CNAP Monitor 500 HD, CNAP Monitor 500at, CNAP Monitor 500i, TASK FORCE MONITOR 3040, Task Force CORE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| April 12, 2023 | K223332 | Task Force CORE | DXN | Substantially Equivalent | Cnsystems Medizintechnik GmbH | accessdata.fda.gov |
| September 11, 2019 | K183521 | CNAP Monitor | DXN | Substantially Equivalent | Cnsystems Medizintechnik GmbH | accessdata.fda.gov |
| October 17, 2008 | K082599 | NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT | DXN | Substantially Equivalent | Cnsystem Medizintechnik AG | accessdata.fda.gov |
| February 7, 2002 | K014063 | TASK FORCE MONITOR 3040 | DSB | Substantially Equivalent | Cnsystems Medizintechnik GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Plethysmograph, Impedance
Updated April 12, 2023. 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.