510(k) K071575 ยท BZD Ventilator, Non-Continuous (Respirator)
SANDMAN INTRO
| Applicant | Mallinckrodt Developpement France, Pleasanton CA, US |
| Decision | Substantially Equivalent, Sep 10, 2007 |
| Received | Jun 8, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071575
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.