510(k) K843538 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
PO 2 LYTRODE
| Applicant | Polystan C/O Vitalcor, Inc., Ballerup Denmark, US |
| Decision | Substantially Equivalent, Oct 18, 1984 |
| Received | Sep 7, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843538
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.