510(k) K012554 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR AUTO CPAP SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jan 29, 2002 |
| Received | Aug 8, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012554
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.