510(k) K121195 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
| Applicant | Ninepoint Medical, Inc., Hillsborough CA, US |
| Decision | Substantially Equivalent, Jul 25, 2012 |
| Received | Apr 19, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121195
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.