510(k) K181070 ยท NBW System, Test, Blood Glucose, Over The Counter
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Feb 1, 2019 |
| Received | Apr 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181070
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.