510(k) K121379 ยท CBK Ventilator, Continuous, Facility Use
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
| Applicant | Airon Corporation, Melbourne FL, US |
| Decision | Substantially Equivalent, Oct 11, 2012 |
| Received | May 8, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121379
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.