510(k) K962638 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
TONOCAP, TC-200 AND ACCESSORY CATHETERS
| Applicant | Instrumentarium Corp., Tewksbury MA, US |
| Decision | Substantially Equivalent, Apr 4, 1997 |
| Received | Jul 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962638
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.