510(k) K193590 ยท NBW System, Test, Blood Glucose, Over The Counter
CareSens S Fit BT Blood Glucose Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Jan 17, 2020 |
| Received | Dec 23, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193590
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.