510(k) K080515 ยท LNH System, Nuclear Magnetic Resonance Imaging
FMRI HARDWARE SYSTEM
| Applicant | Nordicneurolab, Bergen, NO |
| Decision | Substantially Equivalent, May 16, 2008 |
| Received | Feb 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2017 | NordicNeuroLab AS fMRI Hardware System - AudioSystem, Version 1.0
The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.