510(k) K983112 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
RESPIRATORY HUMIDIFIER, MODEL # MR850
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Nov 10, 1998 |
| Received | Sep 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2008 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.
lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patien Terminated |
BTT | None listed |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT110 Terminated |
BTT | None listed |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111 Terminated |
BTT | None listed |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210 Terminated |
BTT | None listed |
| Mar 29, 2006 | Fisher & Paykel Healthcare Inc Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211 Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.