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 |