510(k) K070210 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, Apr 20, 2007 |
| Received | Jan 22, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2014 | GE Healthcare, LLC GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System.
Product Usage:
The T-Piece Resuscitation System [ventilator, emergency powered resusci Terminated |
BTL | None listed |
| Feb 3, 2014 | GE Healthcare Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M12414 Terminated |
BTL | None listed |
| Feb 3, 2014 | GE Healthcare Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com***
Provides the basic equ Terminated |
BTL | None listed |
| Feb 8, 2013 | GE Healthcare, LLC GE Healthcare - Giraffe and Panda T-Piece Resuscitation System
The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic Terminated |
BTL | None listed |
| Dec 26, 2012 | GE Healthcare, LLC GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece D Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.