The following data is part of a premarket notification filed by Promaxo, Inc. with the FDA for Promaxo Mri System.
| Device ID | K202518 |
| 510k Number | K202518 |
| Device Name: | Promaxo MRI System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Promaxo, Inc. 70 Washington St, Suite 407 Oakland, CA 94607 |
| Contact | Eva Hellman |
| Correspondent | Eva Hellman Promaxo, Inc. 70 Washington St, Suite 407 Oakland, CA 94607 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-01 |
| Decision Date | 2021-03-03 |