510(k) K101597 ยท NBW System, Test, Blood Glucose, Over The Counter
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
| Applicant | Agamatrix, Salem NH, US |
| Decision | Substantially Equivalent, Oct 18, 2010 |
| Received | Jun 8, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101597
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.