510(k) K170614 ยท NBW System, Test, Blood Glucose, Over The Counter
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Oct 19, 2017 |
| Received | Mar 1, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170614
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.