510(k) K133584 ยท CGA Glucose Oxidase, Glucose
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Eoshealth, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 8, 2014 |
| Received | Nov 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2016 | Livongo Health The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.