510(k) K112546 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
O_TWO CPAP SYSTEM
| Applicant | O-Two Medical Technologies, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Dec 27, 2011 |
| Received | Sep 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112546
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.