510(k) K160365 ยท NBW System, Test, Blood Glucose, Over The Counter
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
| Applicant | Infopia Co, Ltd., Anyang, KR |
| Decision | Substantially Equivalent, Sep 28, 2016 |
| Received | Feb 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160365
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.