510(k) K083099 ยท NBW System, Test, Blood Glucose, Over The Counter
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
| Applicant | Eps Bio Technology Corp., Hsinchu City, TW |
| Decision | Substantially Equivalent, Jan 16, 2009 |
| Received | Oct 20, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083099
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | Oak Tree International Holdings, LLC, Inc. EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.