510(k) K923618 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
PEEP VALVE
| Applicant | International Respiratory Systems, Inc., Newburgh NY, US |
| Decision | Substantially Equivalent, Aug 3, 1992 |
| Received | Jul 21, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | None listed |
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | None listed |
| Jan 15, 2019 | Westmed, Inc. Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only. Terminated |
BYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.