510(k) K101312 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NUVUE COLORMARK9TM) NEEDLE
| Applicant | Nuvue Therapeutics, Inc., Fairfax VA, US |
| Decision | Substantially Equivalent, Feb 4, 2011 |
| Received | May 11, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101312
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.