510(k) K132288 ยท NBW System, Test, Blood Glucose, Over The Counter
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
| Applicant | I-Sens, Inc., Seoul, Korea, KR |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Jul 23, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132288
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.