510(k) K070247 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, Apr 20, 2007 |
| Received | Jan 25, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070247
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Datex-Ohmeda Inc Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator)
Product identifiers: 2082663-001, 2082663-002, M1241424
Product impacted only if service blender M1091607- Open, Classified |
BTM | None listed |
| Feb 25, 2014 | GE Healthcare, LLC GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System.
Product Usage:
The Bag and Mask Resuscitation System provides the basic equipme Terminated |
BTM | None listed |
| Feb 3, 2014 | GE Healthcare Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***.
Provides the basic equipment required Terminated |
BTM | None listed |
| Feb 3, 2014 | GE Healthcare Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***
Provides the basic equip Terminated |
BTM | None listed |
| Feb 8, 2013 | GE Healthcare, LLC Giraffe and Panda Bag and Mask Resuscitation System
The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.