510(k) K171678 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
| Applicant | Vyaire Medical, Inc., Helsinki, FI |
| Decision | Substantially Equivalent, Apr 30, 2018 |
| Received | Jun 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171678
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.