GIRAFFE AND PANDA WARMERS
FDA 510(k) clearance K122267 · decided 2012-10-02
Clearance details
- K-number
- K122267
- Device name
- GIRAFFE AND PANDA WARMERS
- Applicant
- Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-30
- Decision date
- 2012-10-02
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Laurel, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates recall (Z-1547-2014) | GE Healthcare | 2014-05-06 |
| Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonat recall (Z-1548-2014) | GE Healthcare | 2014-05-06 |
| Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat recall (Z-1549-2014) | GE Healthcare | 2014-05-06 |
| Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to recall (Z-1550-2014) | GE Healthcare | 2014-05-06 |
| GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant war recall (Z-1072-2014) | GE Healthcare, LLC | 2014-02-25 |