510(k) K110383 ยท BZD Ventilator, Non-Continuous (Respirator)
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
| Applicant | A Plus Medical, Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 1, 2011 |
| Received | Feb 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2019 | Galemed Corporation Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562 Terminated |
BZD | None listed |
| Dec 20, 2019 | Galemed Corporation Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559 Terminated |
BZD | None listed |
| Dec 20, 2019 | Galemed Corporation Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802 Terminated |
BZD | None listed |
| Nov 7, 2019 | TELEFLEX-MORRISVILLE Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators. Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.