510(k) K122627 ยท CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
GIO DIGITAL PRESSURE GUAGES
| Applicant | Galemed Corp., Temecula CA, US |
| Decision | Substantially Equivalent, Aug 22, 2013 |
| Received | Aug 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122627
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.