MODIFICATION TO: GIRAFFE AND PANDA WARMER— 510(k) K090697
Substantially EquivalentOhmeda Medical
FDA 510(k) clearance K090697 for MODIFICATION TO: GIRAFFE AND PANDA WARMER, Substantially Equivalent on 2009-04-16. Applicant: Ohmeda Medical. Device class: 2.
Clearance details
- Applicant
- Ohmeda Medical
- Product code
- Code FMT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5130
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Laurel, MD, US
Recent devices under product code FMT
view allMore clearances from Ohmeda Medical
view allAdverse events under product code FMT
product code FMT- Death
- 4
- Malfunction
- 3,074
- Total
- 3,078
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 K090697
K-number listed on FDA's recall record- Z-0481-2019 — Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
- Z-0482-2019 — Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
- Z-0483-2019 — Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
- Z-0484-2019 — Panda Wall Mount warmer. Infant radiant warmer
- Z-1508-2017 — Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide 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
- Z-1072-2014 — GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090697.
Data sourced from openFDA. This site is unofficial and independent of the FDA.