Carevent Atv+ and Carevent MRI
FDA 510(k) K051469 · O-Two Medical Technologies, Inc.
510(k) numberK051469
Submission
- Device name
- Carevent Atv+ and Carevent MRI
- Applicant
- O-Two Medical Technologies, Inc.
Mississauga, CA - Received
- June 3, 2005
- Decision date
- September 28, 2005
- 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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| 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
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| K173205 | Equinox AdvantageBZR · Traditional | 08/29/2018SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | 03/16/2015SE |
| K113687 | Equinox RelieveBZR · Traditional | 04/30/2012SE |
| K112546 | O_Two CPAP SystemBYE · Traditional | 12/27/2011SE |
| K093862 | Carevent Handheld CPAP SystemBTL · Traditional | 05/06/2010SE |
| K081330 | Carevent Par (Public Access Resuscitator)BTL · Traditional | 03/06/2009SE |
| K051889 | Carevent Ca and DraBTL · Special | 08/30/2005SE |
Questions and answers
When was Carevent Atv+ and Carevent MRI cleared by the FDA?
Carevent Atv+ and Carevent MRI (K051469) received a 510(k) decision of Substantially Equivalent on September 28, 2005, 117 days after the submission was received.
What is the product code of K051469?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.