Data / Medical devices / Argentina / Tecme SA
Tecme SA: FDA-registered device maker in Cordoba, Argentina, 2 510(k) clearances
Tecme SA is registered with the FDA (registration 3009302812) in Cordoba, Argentina. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 27, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009302812
- Address
- Av. Circunvalacion (N-O) Agustin Tosco 3040, Cordoba, Argentina, X5008HJY
- Owner or operator
- Tecme S.A. (10034919)
- Roles
- Manufacturer
- First device listed
- January 16, 2011
- Registered through
- 2026
- Brand names listed
- GraphNet Advance, GraphNet Neo, GraphNet TS, Neumovent GraphNet Advance, Neumovent GraphNet Neo, Neumovent GraphNet Ts, Neumovent Schiller GraphNet Advance, Neumovent Schiller GraphNet Neo and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 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 |
|---|---|---|---|---|---|---|
| January 27, 2012 | K111595 | NEUMOVENT GRAPHNET | CBK | Substantially Equivalent | Tecme S.A. | accessdata.fda.gov |
| December 7, 2010 | K101401 | NEUMOVENT GRAPHNET MODEL 3179L1V | CBK | Substantially Equivalent | Tecme S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Continuous, Facility Use
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
Updated January 27, 2012. 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.