510(k) K122610 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
| Applicant | Sen MU Technology Co., Ltd., Kaohsiung City, TW |
| Decision | Substantially Equivalent, Aug 5, 2013 |
| Received | Aug 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122610
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.