The following data is part of a premarket notification filed by Amra Medical Ab with the FDA for Amra Profiler.
| Device ID | K211983 |
| 510k Number | K211983 |
| Device Name: | AMRA Profiler |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | AMRA Medical AB Badhusgatan 5 Linkoping, SE 582 22 |
| Contact | Eric Converse |
| Correspondent | Raymond Kelly Arazy Group 3422 Leonardo Lane New Smyrna Beach, FL 32168 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-25 |
| Decision Date | 2021-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350140460312 | K211983 | 000 |