Data / Medical devices / France / Dyn'r
Dyn'r: FDA-registered device maker in GARDANNE. Bouches-du-Rhone, France, 3 510(k) clearances
Dyn'r is registered with the FDA (registration 3008317830) in GARDANNE. Bouches-du-Rhone, France. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 19, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008317830
- Address
- 1480 Avenue Armenie Pole Yvon Morandat, GARDANNE. Bouches-du-Rhone, France, 13120
- Owner or operator
- Dyn'R (10031870)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 17, 2010
- Registered through
- 2026
- Brand names listed
- Mouthpiece for SDX System, Nose Clip for SDX System, SDX Calibration Syringe, SDX System, SDX System special edition with Gating Module, SDX System with Gating Module
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Volume, Gas | BXW | 1 | Exporter to the US | accessdata.fda.gov |
| Clip, Nose | BXJ | 1 | Exporter to the US | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Exporter to the US | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Exporter to the US | accessdata.fda.gov |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 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 |
|---|---|---|---|---|---|---|
| October 19, 2012 | K121845 | SDX SYSTEM | IYE | Substantially Equivalent | Dyn'R Sas | accessdata.fda.gov |
| January 11, 2010 | K092479 | SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL | IYE | Substantially Equivalent | Dyn'R | accessdata.fda.gov |
| July 13, 1994 | K942779 | DISPOSABLE BACTERIOLOGICAL FILTER | BZG | Substantially Equivalent | Vitalograph, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Spirometer, Diagnostic
- All makers of Mouthpiece, Breathing
- All makers of Clip, Nose
- All makers of System, Radiation Therapy, Charged-Particle, Medical
- All makers of Calibrator, Volume, Gas
Updated October 19, 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.