The following data is part of a premarket notification filed by Amra Medical Ab with the FDA for Amra Profiler.
| Device ID | K173749 |
| 510k Number | K173749 |
| Device Name: | AMRA Profiler |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | AMRA Medical AB Badhusgatan 5 Linkoping, SE 58222 |
| Contact | Janne West |
| Correspondent | Raymond Kelly Licensale Inc 68 Southwood Ter Southbury, CT 06488 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-08 |
| Decision Date | 2018-12-06 |