Positive End Expiratory Pressure Valve
FDA 510(k) K802943 · Fraser Harlake, Inc.
510(k) numberK802943
Submission
- Device name
- Positive End Expiratory Pressure Valve
- Applicant
- Fraser Harlake, Inc.
Mchenry, IL, US - Received
- November 19, 1980
- Decision date
- January 15, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K841903 | Fraser Harlake Emerg. Care Suction SysBTA · Traditional | 06/14/1984SE |
| K833799 | Sphygomano MeterDXN · Traditional | 05/14/1984SE |
| K841496 | Fraser Harlake Hope III ResuscitatorBTM · Traditional | 04/24/1984SE |
| K833692 | Fraser Harlake Dental Anti-Polution SysCBN · Traditional | 11/29/1983SE |
| K833151 | Boyle System Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
| K831427 | Cyprane Tec 4 Continuous Flow Vapor.CAD · Traditional | 07/07/1983SE |
| K822040 | Powered Emergency VentilatorCBK · Traditional | 08/19/1982SE |
| K821744 | Fraser Harlake Nitronox ScavengerCBN · Traditional | 06/25/1982SE |
Questions and answers
When was Positive End Expiratory Pressure Valve cleared by the FDA?
Positive End Expiratory Pressure Valve (K802943) received a 510(k) decision of Substantially Equivalent on January 15, 1981, 57 days after the submission was received.
What is the product code of K802943?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.