510(k) K083468 ยท NBW System, Test, Blood Glucose, Over The Counter
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Feb 10, 2009 |
| Received | Nov 24, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083468
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.