Mark III Oxygen Walker System
FDA 510(k) K820836 · Union Carbide Corp.
510(k) numberK820836
Submission
- Device name
- Mark III Oxygen Walker System
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- March 26, 1982
- Decision date
- April 15, 1982
- 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
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| 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 |
More from Caire, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830337 | Mark III Oxygen Walker Sys-Low PressBYJ · Traditional | 03/17/1983SE |
| K820535 | Laser Gas MixturesEWG · Traditional | 03/31/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
| K802436 | Centrifichem AlbuminCIX · Traditional | 10/31/1980SE |
Questions and answers
When was Mark III Oxygen Walker System cleared by the FDA?
Mark III Oxygen Walker System (K820836) received a 510(k) decision of Substantially Equivalent on April 15, 1982, 20 days after the submission was received.
What is the product code of K820836?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.