510(k) K020332 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
RESPIRATORY HUMIDIFIER, MODEL MR850
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, Auckland, NZ |
| Decision | Substantially Equivalent, Jul 7, 2003 |
| Received | Jan 31, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020332
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2005 | Fisher & Paykel Healthcare Inc RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier. Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.