The following data is part of a premarket notification filed by Syntheticmr Ab with the FDA for Symri.
Device ID | K181093 |
510k Number | K181093 |
Device Name: | SyMRI |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SyntheticMR AB Storgatan 11 Linkoping, SE 582 23 |
Contact | Maria Almesaker |
Correspondent | Raymond Kelly Licensale Inc 68 Southwoods Terrace 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 | 2018-04-25 |
Decision Date | 2018-06-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYMRI 85974094 4661808 Live/Registered |
Synthetic MR AB (publ) 2013-07-01 |