510(k) K980384 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
TRIP TONOMETRY CATHETER, 18F
| Applicant | Datex-Engstrom, Inc., Tewksbury MA, US |
| Decision | Substantially Equivalent, May 1, 1998 |
| Received | Feb 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980384
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.