Mark 4 Liquid Oxygen System
FDA 510(k) K860937 · Puritan Bennett Corp.
510(k) numberK860937
Submission
- Device name
- Mark 4 Liquid Oxygen System
- Applicant
- Puritan Bennett Corp.
Overland Park, KS, US - Received
- March 12, 1986
- Decision date
- March 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYJ – Unit, Liquid-Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5655
- Specialty
- Anesthesiology
Other 510(k)s with product code BYJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 07/19/2013SE |
| K113767 | Mounted Medical Oxygen SystemBYJ · Traditional | Essex Industries, Inc. | 06/29/2012SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | Precision Medical, Inc. | 04/21/2011SE |
| K101272 | Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional | Essex Industries, Inc. | 08/20/2010SE |
| K081779 | GOLOX-93BYJ · Traditional | Respironics, Inc. | 09/19/2008SE |
| K080023 | Modification to: SpiritBYJ · Special | Caire, Inc. | 06/16/2008SE |
| K072723 | Respironics GoloxBYJ · Traditional | Respironics, Inc. | 03/20/2008SE |
| K072011 | Copd Liquid Oxygen Portable, Model 300PBYJ · Traditional | Copd Partners, Inc. | 10/18/2007SE |
| K071581 | Backpack Medical Oxygen SystemBYJ · Traditional | Essex Cryogenics of Missouri, Inc. | 07/11/2007SE |
| K050153 | Spirit, Model HasBYJ · Traditional | Caire, Inc. | 04/15/2005SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K063650 | Ventilator with Respiratory Mechanics, Model 840CBK · Special | 02/15/2007SE |
| K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionCBK · Traditional | 04/04/2006SE |
| K023225 | Puritan Bennett Dataflow Data Management SoftwareBZG · Abbreviated | 12/18/2002SE |
| K022103 | Puritan-Bennett 700 Renaissance II Spirometry SystemBZG · Special | 09/27/2002SE |
| K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionCBK · Special | 08/13/2002ST |
| K001646 | Puritan-Bennett 840 Ventilator System with Neomode OptionCBK · Traditional | 10/20/2000ST |
| K002001 | Breeze Sleepgear with DreamsealBZD · Special | 09/06/2000SE |
| K993071 | Puritan-Bennett Ventilator System with Et/Tracheostomy Tube Compensation, TC, Option…CBK · Special | 11/24/1999ST |
| K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemBYJ · Special | 10/22/1999SE |
| K993088 | Puritan-Bennett Aeris 590 Oxygen Concentrator with OciCAW · Special | 10/08/1999SE |
Questions and answers
When was Mark 4 Liquid Oxygen System cleared by the FDA?
Mark 4 Liquid Oxygen System (K860937) received a 510(k) decision of Substantially Equivalent on March 20, 1986, 8 days after the submission was received.
What is the product code of K860937?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.