510(k) K083265 ยท NBW System, Test, Blood Glucose, Over The Counter
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
| Applicant | Agamatrix, Inc., Salem NH, US |
| Decision | Substantially Equivalent, Feb 3, 2009 |
| Received | Nov 5, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083265
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.