510(k) K000959 ยท CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
CRITERION 60 OR PM 60
| Applicant | Caradyne, Ltd., Mccordsville IN, US |
| Decision | Substantially Equivalent, Jun 22, 2000 |
| Received | Mar 24, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K000959
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.