Neopip Patient Circuit with Peep
FDA 510(k) K103833 · Neoforce Group, Inc.
510(k) numberK103833
Submission
- Device name
- Neopip Patient Circuit with Peep
- Applicant
- Neoforce Group, Inc.
Ivyland, PA, US - Received
- December 30, 2010
- Decision date
- April 20, 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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| 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 |
| 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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| K110119 | Pressure ManometerCAP · Traditional | 06/10/2011SE |
| K102649 | Neopop Infant Resuscitator with Flow MeterBTM · Traditional | 01/06/2011SE |
| K092085 | Ispira Resuscitation UnitBTL · Traditional | 10/07/2009SE |
| K072021 | Neopip Infant ResuscitatorBTM · Traditional | 09/12/2007SE |
| K070416 | Neopeep Neonatal Resuscitation Circuit with PeepBYE · Traditional | 05/29/2007SE |
| K061280 | V-2200 Infant IncubatorFMZ · Traditional | 06/27/2006SE |
Questions and answers
When was Neopip Patient Circuit with Peep cleared by the FDA?
Neopip Patient Circuit with Peep (K103833) received a 510(k) decision of Substantially Equivalent on April 20, 2011, 111 days after the submission was received.
What is the product code of K103833?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.