GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
FDA 510(k) clearance K070210 · decided 2007-04-20
Clearance details
- K-number
- K070210
- Device name
- GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 2007-01-22
- Decision date
- 2007-04-20
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- BTL
- Device class
- 2
- Regulation number
- 868.5925
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Laurel, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant recall (Z-1070-2014) | GE Healthcare, LLC | 2014-02-25 |
| Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 20 recall (Z-0916-2014) | GE Healthcare | 2014-02-03 |
| Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled recall (Z-0917-2014) | GE Healthcare | 2014-02-03 |
| GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation S recall (Z-0748-2013) | GE Healthcare, LLC | 2013-02-08 |
| GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circ recall (Z-0606-2013) | GE Healthcare, LLC | 2012-12-26 |