510(k) K180902 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
| Applicant | Medipines Corporation, Anaheim Hill CA, US |
| Decision | Substantially Equivalent, Jan 11, 2019 |
| Received | Apr 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180902
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.