510(k) K854357 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
GEM-6, WITH COMPONENTS
| Applicant | Diamond Electro-Tech, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jan 8, 1986 |
| Received | Oct 29, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854357
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.