Data / Medical devices / Mexico / General Commerce & Trade, S.A. De C.V.
General Commerce & Trade, S.A. De C.V.: FDA-registered device maker in Monterrey Nuevo Leon, Mexico, 4 510(k) clearances
General Commerce & Trade, S.A. De C.V. is registered with the FDA (registration 3044744649) in Monterrey Nuevo Leon, Mexico. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 10, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044744649
- Address
- San Fernando 837 2do Piso, Col. Mitras Norte, Monterrey Nuevo Leon, Mexico, 64320
- Owner or operator
- General Commerce & Trade, S.A. de C.V. (10095738)
- Roles
- Exporter to the US
- First device listed
- April 21, 2026
- Registered through
- 2026
- Brand names listed
- GE LOGIQ P7, GE LOGIQ S7, GE Lunar Bone Densitometer, GE VOLUSON P8
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Densitometer, Bone | KGI | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| February 10, 2017 | K163596 | LOGIQ P9 and LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 2, 2016 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| April 26, 2016 | K160162 | Voluson P6, Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 26, 2016 | K160182 | LOGIQ S7 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
Compare with other makers
- All makers of Densitometer, Bone
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated February 10, 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.