510(k) K151978 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 15, 2016 |
| Received | Jul 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151978
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.