GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
FDA 510(k) clearance K070247 · decided 2007-04-20
Clearance details
- K-number
- K070247
- Device name
- GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 2007-01-25
- Decision date
- 2007-04-20
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Laurel, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitato recall (Z-2357-2026) | Datex-Ohmeda Inc | 2026-06-18 |
| GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone In recall (Z-1071-2014) | GE Healthcare, LLC | 2014-02-25 |
| Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE recall (Z-0914-2014) | GE Healthcare | 2014-02-03 |
| Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled recall (Z-0915-2014) | GE Healthcare | 2014-02-03 |
| Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [vent recall (Z-0749-2013) | GE Healthcare, LLC | 2013-02-08 |