510(k) K091820 ยท NBW System, Test, Blood Glucose, Over The Counter
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
| Applicant | Bayer Healthcare, Mishawaka IN, US |
| Decision | Substantially Equivalent, Aug 26, 2009 |
| Received | Jun 18, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091820
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.