510(k) K041209 ยท BZD Ventilator, Non-Continuous (Respirator)
RESMED S8 PIONEER CPAP SYSTEM
| Applicant | Resmed, Ltd., Poway CA, US |
| Decision | Substantially Equivalent, Jul 1, 2004 |
| Received | May 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2007 | Resmed Corporation ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #3300 Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.