510(k) K180866 ยท NBW System, Test, Blood Glucose, Over The Counter
CareSens S Fit Blood Glucose Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Aug 31, 2018 |
| Received | Apr 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180866
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.