510(k) K802583 ยท CBK Ventilator, Continuous, Facility Use
INFANT VENTILATOR, (RESPIRATOR) PLAN B
| Applicant | Healthdyne, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 18, 1980 |
| Received | Oct 20, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802583
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.