510(k) K092029 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
| Applicant | Draeger Medical AG & Co. KG, Telford PA, US |
| Decision | Substantially Equivalent, Aug 6, 2010 |
| Received | Jul 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Draeger, Inc. VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310
Disposable breathing circuit for use with a resuscitation module. Open, Classified |
BYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.