510(k) K030515 ยท CBK Ventilator, Continuous, Facility Use
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
| Applicant | Hans Rudolph, Inc., Kansas City MO, US |
| Decision | Substantially Equivalent, May 2, 2003 |
| Received | Feb 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030515
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.