Data / Medical devices / Germany / PAR MEDIZINTECHNIK GMBH & Co. KG
PAR MEDIZINTECHNIK GMBH & Co. KG: FDA-registered device maker in Berlin, Germany, 2 510(k) clearances
PAR MEDIZINTECHNIK GMBH & Co. KG is registered with the FDA (registration 3001744144) in Berlin, Germany. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 14, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001744144
- Address
- Rigistr. 11, Berlin, Germany, D-12277
- Owner or operator
- PAR MEDIZINTECHNIK GMBH & Co. KG (9046872)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- TONOPORT V, TONOPORT VI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| June 14, 2017 | K170966 | TONOPORT VI | DXN | Substantially Equivalent | Par Medizintechnik GmbH & Co. KG | accessdata.fda.gov |
| November 9, 2001 | K012647 | TONOPORT V | DXN | Substantially Equivalent | Par Medizintechnik GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
Updated June 14, 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.