Data / Medical devices / United States / Magnus Medical Inc.
Magnus Medical Inc.: FDA-registered device maker in Burlingame, CA, United States, 1 510(k) clearance
Magnus Medical Inc. is registered with the FDA (registration 3018708317) in Burlingame, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018708317
- Address
- 1350 Old Bayshore Highway Suite 600, Burlingame, CA, United States, 94010
- Owner or operator
- Magnus Medical Inc. (10086208)
- Roles
- Manufacturer
- First device listed
- October 21, 2022
- Registered through
- 2026
- Brand names listed
- SAINT Neuromodulation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Manufacturer | accessdata.fda.gov |
| Transcranial Magnetic Stimulator | OBP | 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 |
|---|---|---|---|---|---|---|
| September 1, 2022 | K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K | OBP | Substantially Equivalent | Magnus Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Neurological Stereotaxic Instrument
- All makers of Transcranial Magnetic Stimulator
Updated September 1, 2022. 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.