Valve, Ambu Peep
FDA 510(k) K782152 · Narco Air-Shields
510(k) numberK782152
Submission
- Device name
- Valve, Ambu Peep
- Applicant
- Narco Air-Shields
Houston, TN, US - Received
- December 26, 1978
- Decision date
- December 26, 1978
- Decision
- Unknown (SESP)
- 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
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| 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
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|---|---|---|
| K820114 | System V.Heart Rate/Respir. Rate Monit.DRT · Traditional | 02/12/1982SE |
| K810953 | Model 533 Phototherapy UnitLBI · Traditional | 04/23/1981SE |
| K810474 | Probe CoverFLL · Traditional | 03/31/1981SE |
| K802800 | Narco Air-Sheilds Sys. 100 Monitor SysDXG · Traditional | 11/24/1980SE |
| K802126 | Isolette Incubator C-100FMZ · Traditional | 09/26/1980SE |
| K792592 | Ambu Universal Suction PumpJCX · Traditional | 01/11/1980SE |
| K792499 | Ambu Paedi Anaesthesia SystemCAI · Traditional | 12/19/1979SE |
| K792118 | Air-Shields ResuscitatorsBTM · Traditional | 11/13/1979SE |
| K792117 | Air-Shields Heart Rate MonitorDRT · Traditional | 11/13/1979SE |
| K790552 | AS7 & AS8 MonitorsDRT · Traditional | 05/01/1979SE |
Questions and answers
When was Valve, Ambu Peep cleared by the FDA?
Valve, Ambu Peep (K782152) received a 510(k) decision of Unknown on December 26, 1978, 0 days after the submission was received.
What is the product code of K782152?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.