Data / Medical devices / Netherlands / Lode B.V.
Lode B.V.: FDA-registered device maker in Groningen, Netherlands, 3 510(k) clearances
Lode B.V. is registered with the FDA (registration 8030476) in Groningen, Netherlands. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 21, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030476
- FEI number
- 1000601592
- Address
- Zernikepark 16, Groningen, Netherlands, 9747 AN
- Owner or operator
- LODE B.V. (9019791)
- Roles
- Manufacturer
- First device listed
- February 25, 1999
- Registered through
- 2026
- Brand names listed
- Angio cpet - single set, Angio cpet - with automatic stand, Angio cpet - with electrical adjustable wall mount, Angio cpet - with static wall mount, Angio imaging fixation set, Angio imaging support radiology, Angio imaging support ultrasound, Angio rehab and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Measuring | ISD | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Treadmill, Powered | IOL | 1 | 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 |
|---|---|---|---|---|---|---|
| December 21, 2020 | K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra | ISD | Substantially Equivalent | Lode B.V. | accessdata.fda.gov |
| June 7, 2006 | K060820 | CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 | DXN | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| June 18, 1985 | K851097 | LODE MODEL CORIVAL ERGOMETER | ISD | Substantially Equivalent | Lode Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Exerciser, Measuring
- All makers of Treadmill, Powered
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter, Tissue Saturation
Updated December 21, 2020. 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.