510(k) K023135 ยท CBK Ventilator, Continuous, Facility Use
IMAGE3 SE DISPOSABLE FULL FACE MASK
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jan 3, 2003 |
| Received | Sep 20, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K023135
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.