Devilbiss Model 7351 Series
FDA 510(k) K894424 · Devilbiss Health Care, Inc.
510(k) numberK894424
Submission
- Device name
- Devilbiss Model 7351 Series
- Applicant
- Devilbiss Health Care, Inc.
Somerset, PA, US - Received
- July 17, 1989
- Decision date
- September 18, 1989
- 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 |
|---|---|---|
| K963349 | Devilbiss 8650DBTI · Traditional | 06/13/1997SE |
| K970289 | Compressor/Nebulizer #3650CAF · Traditional | 04/15/1997SE |
| K961126 | Pulse Dose SeriesNFB · Traditional | 10/21/1996SE |
| K950849 | Model #7354BZD · Traditional | 02/08/1996SE |
| K952491 | Model 7355BZD · Traditional | 01/31/1996SE |
| K952249 | Jet NebulizerCAF · Traditional | 01/30/1996SE |
| K953815 | 5 LPM Oxygen ConcentratorCAW · Traditional | 11/09/1995SE |
| K952037 | 3 LPM Oxygen ConcentratorCAW · Traditional | 09/06/1995SE |
| K946095 | Devilbiss Model 5500CAF · Traditional | 08/24/1995SE |
| K944611 | Model# 7500 SurveyorMNR · Traditional | 04/21/1995SE |
Questions and answers
When was Devilbiss Model 7351 Series cleared by the FDA?
Devilbiss Model 7351 Series (K894424) received a 510(k) decision of Substantially Equivalent on September 18, 1989, 63 days after the submission was received.
What is the product code of K894424?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.