Disposable Adjustable Peep Valve MR Conditional Use
FDA 510(k) K133957 · Galemed Corp.
510(k) numberK133957
Submission
- Device name
- Disposable Adjustable Peep Valve MR Conditional Use
- Applicant
- Galemed Corp.
Xiamen, Fujian, CN - Received
- December 23, 2013
- Decision date
- April 14, 2014
- 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 |
| 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 |
| K081266 | Mercury Medical Peep ValveBYE · Traditional | Mercury Enterprizes Dba Mercury Medical | 03/05/2009SE |
More from Mercury Enterprizes Dba Mercury Medical
| 510(k) | Device | Decision |
|---|---|---|
| K132679 | Af Viral/Bacterial Filter, BF Viral/Bacterial FilterCAH · Traditional | 04/18/2014SE |
| K122627 | Gio Digital Pressure GuagesCAP · Traditional | 08/22/2013SE |
| K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep…BTM · Traditional | 10/15/2008SE |
| K072755 | Galemed CPAP MaskBZD · Traditional | 11/16/2007SE |
| K022124 | Galemed Peak Flow Meter, Models 3751/3752BZH · Traditional | 04/03/2003SE |
| K021742 | Galemed Neb-Easy NebulizerCAF · Traditional | 10/25/2002SE |
Questions and answers
When was Disposable Adjustable Peep Valve MR Conditional Use cleared by the FDA?
Disposable Adjustable Peep Valve MR Conditional Use (K133957) received a 510(k) decision of Substantially Equivalent on April 14, 2014, 112 days after the submission was received.
What is the product code of K133957?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.