510(k) K961335 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
GEM PREMIER PLUS MODEL 5500
| Applicant | Mallinckrodt Sensor Systems, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jun 28, 1996 |
| Received | Apr 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961335
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.