510(k) K150833 ยท NBW System, Test, Blood Glucose, Over The Counter
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Dec 4, 2015 |
| Received | Mar 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150833
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.