510(k) K173591 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, Mar 28, 2018 |
| Received | Nov 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173591
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.