GIRAFFE AND PANDA WARMERS— 510(k) K101804
Substantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.
FDA 510(k) clearance K101804 for GIRAFFE AND PANDA WARMERS, Substantially Equivalent on 2010-07-21. Applicant: Ohmeda Medical, A Division of Datex-Ohmeda, Inc.. Device class: 2.
Clearance details
- Applicant
- Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- 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, A Division of Datex-Ohmeda, Inc.
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 K101804
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-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 K101804.
Data sourced from openFDA. This site is unofficial and independent of the FDA.