Liquid Oxygen Storage Subsystem
FDA 510(k) K941819 · Hogan & Hartson
510(k) numberK941819
Submission
- Device name
- Liquid Oxygen Storage Subsystem
- Applicant
- Hogan & Hartson
Washington, DC, US - Received
- April 13, 1994
- Decision date
- May 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYJ – Unit, Liquid-Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5655
- Specialty
- Anesthesiology
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|---|---|---|---|
| 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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| K946217 | Cardiolipin M Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946216 | Cardiolipin a Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946215 | Cardiolipin G Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946186 | CHAL-2500IPF · Traditional | 08/14/1995SN |
| K941566 | CompuspeakLLZ · Traditional | 06/30/1995SE |
Questions and answers
When was Liquid Oxygen Storage Subsystem cleared by the FDA?
Liquid Oxygen Storage Subsystem (K941819) received a 510(k) decision of Substantially Equivalent on May 23, 1994, 40 days after the submission was received.
What is the product code of K941819?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.