510(k) K123935 ยท NBW System, Test, Blood Glucose, Over The Counter
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
| Applicant | Andon Medical Co., Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Apr 12, 2013 |
| Received | Dec 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123935
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.