The following data is part of a premarket notification filed by Magnus Medical, Inc. with the FDA for Magnus Neuromodulation System (mns) With Saint Technology, Model Number 1001k.
| Device ID | K220177 |
| 510k Number | K220177 |
| Device Name: | Magnus Neuromodulation System (MNS) With SAINT Technology, Model Number 1001K |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Magnus Medical, Inc. 1350 Old Bayshore Highway Suite 600 Burlingame, CA 94010 |
| Contact | Brett Wingeier |
| Correspondent | Susan Noreiga Magnus Medical, Inc. 1350 Old Bayshore Highway Suite 600 Burlingame, CA 94010 |
| Product Code | OBP |
| Subsequent Product Code | GWF |
| Subsequent Product Code | HAW |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-21 |
| Decision Date | 2022-09-01 |