510(k) K130037 ยท BZD Ventilator, Non-Continuous (Respirator)
BREATHE CPAP SYSTEM
| Applicant | Breathe Technologies, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 17, 2013 |
| Received | Jan 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130037
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.