510(k) K082237 ยท BZD Ventilator, Non-Continuous (Respirator)
PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
| Applicant | Mallinckrodt Developpement France, Boulder CO, US |
| Decision | Substantially Equivalent, Oct 9, 2008 |
| Received | Aug 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082237
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.