510(k) K003497 ยท CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
DISPOSABLE PRESSURE MONITOR
| Applicant | Engineered Medical Systems, Mccordsville IN, US |
| Decision | Substantially Equivalent, Nov 30, 2000 |
| Received | Nov 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003497
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.