Giraffe and Panda T- Piece Resuscitation System
FDA 510(k) K070210 · Ohmeda Medical
510(k) numberK070210
Submission
- Device name
- Giraffe and Panda T- Piece Resuscitation System
- Applicant
- Ohmeda Medical
Laurel, MD, US - Received
- January 22, 2007
- Decision date
- April 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
More from Mercury Medical
| 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 |
| K090697 | Modification to: Giraffe and Panda WarmerFMT · Special | 04/16/2009SE |
| 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 |
| 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 Giraffe and Panda T- Piece Resuscitation System cleared by the FDA?
Giraffe and Panda T- Piece Resuscitation System (K070210) received a 510(k) decision of Substantially Equivalent on April 20, 2007, 88 days after the submission was received.
What is the product code of K070210?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.