Modification to: Giraffe and Panda Warmer
FDA 510(k) K090697 · Ohmeda Medical
510(k) numberK090697
Submission
- Device name
- Modification to: Giraffe and Panda Warmer
- Applicant
- Ohmeda Medical
Laurel, MD, US - Received
- March 17, 2009
- Decision date
- April 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K201628 | Panda iRes Warmer, Giraffe WarmerFMT · Traditional | GE Healthcare | 02/12/2021SE |
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| K173516 | NuBorne Infant WarmerFMT · Abbreviated | International Biomedical | 08/17/2018SE |
| K123309 | Giraffe and Panda WarmersFMT · Traditional | Ohmeda Medical | 02/05/2013SE |
| K120642 | Resuscitaire with AutobreathFMT · Traditional | Draeger Medical Systems, Inc. | 11/02/2012SE |
| K122267 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 10/02/2012SE |
More from Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123309 | Giraffe and Panda WarmersFMT · Traditional | 02/05/2013SE |
| K101788 | Giraffe OmnibedFMZ · Special | 07/21/2010SE |
| K101778 | Giraffe IncubatorFMZ · Special | 07/21/2010SE |
| K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)FMT · Special | 08/27/2007SE |
| K070377 | Giraffe and Panda WarmerFMT · Traditional | 07/11/2007SE |
| K070247 | Giraffe and Panda Bag and Mask Resuscitation SystemBTM · Traditional | 04/20/2007SE |
| K070210 | Giraffe and Panda T- Piece Resuscitation SystemBTL · Traditional | 04/20/2007SE |
| K040068 | Biliblanket Plus High Output Phototherapy SystemFMZ · Traditional | 04/16/2004SE |
| K020547 | Ohmeda Medical Giraffe IncubatorFMZ · Traditional | 05/09/2002SE |
| K020543 | Ohmeda Medical Giraffe OmnibedFMZ · Traditional | 05/09/2002SE |
Questions and answers
When was Modification to: Giraffe and Panda Warmer cleared by the FDA?
Modification to: Giraffe and Panda Warmer (K090697) received a 510(k) decision of Substantially Equivalent on April 16, 2009, 30 days after the submission was received.
What is the product code of K090697?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.