510(k) K063476 ยท BZD Ventilator, Non-Continuous (Respirator)
BREAS ISLEEP 20I
| Applicant | Breas Medical AB, Molnlycke, SE |
| Decision | Substantially Equivalent, Jan 22, 2007 |
| Received | Nov 16, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063476
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.