510(k) K133957 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
| Applicant | Galemed Corp., Xiamen, Fujian, CN |
| Decision | Substantially Equivalent, Apr 14, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133957
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.