GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM— 510(k) K070247
Substantially EquivalentOhmeda Medical
FDA 510(k) clearance K070247 for GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM, Substantially Equivalent on 2007-04-20. Applicant: Ohmeda Medical. Device class: 2.
Clearance details
- Applicant
- Ohmeda Medical
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laurel, MD, US
Recent devices under product code BTM
view allMore clearances from Ohmeda Medical
view allAdverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K070247
K-number listed on FDA's recall record- Z-2357-2026 — Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance
- Z-0914-2014 — 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 for pulmonary resuscitation of infants.
- Z-0915-2014 — 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 equipment required for pulmonary resuscitation of infant.s
- Z-1071-2014 — 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 equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
- Z-0749-2013 — 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 required for pulmonary resuscitation of infants.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070247.
Data sourced from openFDA. This site is unofficial and independent of the FDA.