510(k) K040862 ยท BZD Ventilator, Non-Continuous (Respirator)
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
| Applicant | Caradyne, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Jun 30, 2004 |
| Received | Apr 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2006 | Respironics, Inc. NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 Terminated |
CBK | None listed |
| Apr 7, 2006 | Respironics, Inc. NeoPAP Neonatal CPAP/Humidification System
(Ventilator, Continuous) Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.