510(k) K080923 ยท NBW System, Test, Blood Glucose, Over The Counter
CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Apr 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080923
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.