510(k) K162564 ยท NBW System, Test, Blood Glucose, Over The Counter
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System
| Applicant | Tianjin Empecs Medical Device Co., Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | Sep 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162564
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.