510(k) K163657 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Quantum Workstation
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, Jan 18, 2017 |
| Received | Dec 23, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163657
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.