510(k) K131230 ยท NBW System, Test, Blood Glucose, Over The Counter
GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
| Applicant | Philosys, Inc., New York NY, US |
| Decision | Substantially Equivalent, Aug 4, 2014 |
| Received | Apr 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131230
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.