510(k) K062347 ยท NBW System, Test, Blood Glucose, Over The Counter
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Bayer Healthcare, LLC, Mishawaka IN, US |
| Decision | Substantially Equivalent, Nov 22, 2006 |
| Received | Aug 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062347
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.