GIRAFFE AND PANDA WARMER
FDA 510(k) clearance K070377 · decided 2007-07-11
Clearance details
- K-number
- K070377
- Device name
- GIRAFFE AND PANDA WARMER
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 2007-02-08
- Decision date
- 2007-07-11
- Days to decision
- 153 days
- Clearance type
- Traditional
- 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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| GIRAFFE AND PANDA WARMERS (K123309) | Ohmeda Medical | 2013-02-05 |
| RESUSCITAIRE WITH AUTOBREATH (K120642) | Draeger Medical Systems, Inc. | 2012-11-02 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant war recall (Z-1072-2014) | GE Healthcare, LLC | 2014-02-25 |
| Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road L recall (Z-2227-2008) | Datex Ohmeda, Inc. dba GE Healthcare | 2008-09-11 |