510(k) K170231 ยท NBW System, Test, Blood Glucose, Over The Counter
iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Sep 15, 2017 |
| Received | Jan 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170231
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.