510(k) K093819 ยท NBW System, Test, Blood Glucose, Over The Counter
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
| Applicant | Arkray Factory USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Jun 9, 2010 |
| Received | Dec 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093819
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.