O_Two CPAP System
FDA 510(k) K112546 · O-Two Medical Technologies, Inc.
510(k) numberK112546
Submission
- Device name
- O_Two CPAP System
- Applicant
- O-Two Medical Technologies, Inc.
Mississauga, CA - Received
- September 1, 2011
- Decision date
- December 27, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | Draeger Medical AG & Co. KG | 08/06/2010SE |
| K090710 | Mercury CPAPBYE · Traditional | Mercury Medical | 08/20/2009SE |
| K090317 | Babi*Plus Bubble Pap ValveBYE · Traditional | A Plus Medical | 05/20/2009SE |
| K081266 | Mercury Medical Peep ValveBYE · Traditional | Mercury Enterprizes Dba Mercury Medical | 03/05/2009SE |
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| K113687 | Equinox RelieveBZR · Traditional | 04/30/2012SE |
| K093862 | Carevent Handheld CPAP SystemBTL · Traditional | 05/06/2010SE |
| K081330 | Carevent Par (Public Access Resuscitator)BTL · Traditional | 03/06/2009SE |
| K051469 | Carevent Atv+ and Carevent MRIBTL · Traditional | 09/28/2005SE |
| K051889 | Carevent Ca and DraBTL · Special | 08/30/2005SE |
Questions and answers
When was O_Two CPAP System cleared by the FDA?
O_Two CPAP System (K112546) received a 510(k) decision of Substantially Equivalent on December 27, 2011, 117 days after the submission was received.
What is the product code of K112546?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.