The following data is part of a premarket notification filed by Nordicneurolab with the FDA for Lcd Monitor.
Device ID | K140956 |
510k Number | K140956 |
Device Name: | LCD MONITOR |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, Hordaland, NO 5009 |
Contact | Chandana G Bhandari |
Correspondent | Chandana G Bhandari NORDICNEUROLAB MOLLENDALSVEIEN 65C Bergen, Hordaland, NO 5009 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-14 |
Decision Date | 2014-08-07 |
Summary: | summary |