510(k) K060657 ยท BZD Ventilator, Non-Continuous (Respirator)
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
| Applicant | Breas Medical AB, Molnlycke, SE |
| Decision | Substantially Equivalent, Aug 18, 2006 |
| Received | Mar 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060657
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.