Data / Medical devices / Netherlands / Cablon Medical B.V.
Cablon Medical B.V.: FDA-registered device maker in LEUSDEN Utrecht, Netherlands, 3 510(k) clearances
Cablon Medical B.V. is registered with the FDA (registration 9614584) in LEUSDEN Utrecht, Netherlands. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 22, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614584
- FEI number
- 3003062786
- Address
- Klepelhoek 11, LEUSDEN Utrecht, Netherlands, 3833 GZ
- Owner or operator
- CABLON MEDICAL B.V. (9037932)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 7, 2007
- Registered through
- 2026
- Brand names listed
- CNERGY Accessory Verification, CNERGY Breath Hold, CNERGY Solutions, PIM (CNERGY Go); TheraView LX; TheraView TBI (CNERGY TBI)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Scanner, Rectilinear, Nuclear | IYW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Synchronizer, Ecg / Respirator, Radiographic | IXO | 1 | Complaint file establishment, 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 22, 1996 | K960510 | THERAVIEW | IYE | Substantially Equivalent | Infimed, Inc. | accessdata.fda.gov |
| March 31, 1992 | K920455 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.) | IYE | Substantially Equivalent | S & S Inficon, Inc. | accessdata.fda.gov |
| August 23, 1990 | K902339 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER | IYE | Substantially Equivalent | S & S Inficon, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Synchronizer, Ecg / Respirator, Radiographic
Updated April 22, 1996. 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.