Koo Americas Valve Peep, Model KM-809
FDA 510(k) K050918 · Koo Americas, Inc.
510(k) numberK050918
Submission
- Device name
- Koo Americas Valve Peep, Model KM-809
- Applicant
- Koo Americas, Inc.
Alpharetta, GA, US - Received
- April 12, 2005
- Decision date
- June 6, 2005
- 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
Other 510(k)s with product code BYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160112 | Besmed PEEP ValveBYE · Traditional | Besmed Health Business Corp | 04/29/2016SE |
| K133957 | Disposable Adjustable Peep Valve MR Conditional UseBYE · Traditional | Galemed Corp. | 04/14/2014SE |
| K133210 | B&B BubblerBYE · Traditional | S & T Medical Technologies, Inc. | 03/28/2014SE |
| K122610 | Plaxtron CPAP System, Model CH-FFM-87XX/CH-FFM-88XX SeriesBYE · Traditional | Sen MU Technology Co., Ltd. | 08/05/2013SE |
| K112546 | O_Two CPAP SystemBYE · Traditional | O-Two Medical Technologies, Inc. | 12/27/2011SE |
| K110713 | Waterpap ValveBYE · Traditional | Airways Development, LLC | 09/12/2011SE |
| K103833 | Neopip Patient Circuit with PeepBYE · Traditional | Neoforce Group, Inc. | 04/20/2011SE |
| 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 |
Questions and answers
When was Koo Americas Valve Peep, Model KM-809 cleared by the FDA?
Koo Americas Valve Peep, Model KM-809 (K050918) received a 510(k) decision of Substantially Equivalent on June 6, 2005, 55 days after the submission was received.
What is the product code of K050918?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.