510(k) K201394 ยท NBW System, Test, Blood Glucose, Over The Counter
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Oct 5, 2021 |
| Received | May 27, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201394
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.