510(k) K041823 ยท BZD Ventilator, Non-Continuous (Respirator)
PIONEER U121 SERIES CPAP
| Applicant | Merits Health Products Co., Ltd., Taichung, TW |
| Decision | Substantially Equivalent, May 10, 2005 |
| Received | Jul 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041823
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.