510(k) K150365 ยท BZD Ventilator, Non-Continuous (Respirator)
Cloud9 System
| Applicant | Insleep Technologies, LLC, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jul 21, 2015 |
| Received | Feb 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150365
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.