510(k) K130696 ยท NBW System, Test, Blood Glucose, Over The Counter
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
| Applicant | I-Sens, Inc., Seoul, Korea, KR |
| Decision | Substantially Equivalent, Aug 21, 2013 |
| Received | Mar 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130696
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.