510(k) K130068
- Device
- DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
- Applicant
- ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
- 510(k) number
- K130068
- Product code
- BYJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-07-19
- Date received
- 2013-01-11
- Regulation
- 868.5655
- Classification name
- Unit, Liquid-oxygen, Portable
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN SEISE
- Address
- 8007 Chivvis Dr. St. Louis MO US 63123 63123
FDA Registration Numbers#
- 3013156250
- 3009128734
- 3004972304
- 1937980
Source Documents#
Other 510(k) Records For Product Code BYJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113767 | MOUNTED MEDICAL OXYGEN SYSTEM | Essex Industries, Inc. | 2012-06-29 |
| K103324 | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | 2011-04-21 |
| K101272 | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 | Essex Industries, Inc. | 2010-08-20 |
| K081779 | GOLOX-93 | Respironics, Inc. | 2008-09-19 |
| K080023 | MODIFICATION TO: SPIRIT | Caire, Inc. | 2008-06-16 |
| K072723 | RESPIRONICS GOLOX | Respironics, Inc. | 2008-03-20 |
| K072011 | COPD LIQUID OXYGEN PORTABLE, MODEL 300P | Copd Partners, Inc. | 2007-10-18 |
| K071581 | BACKPACK MEDICAL OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | 2007-07-11 |
| K050153 | SPIRIT, MODEL HAS | Caire, Inc. | 2005-04-15 |
| K050414 | PLIX | Respironics, Inc. | 2005-04-11 |
| K041122 | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | 2004-10-04 |
| K032143 | LIQUID OXYGEN SYSTEM | Micro Technology Services, Inc. | 2004-03-30 |
| K033000 | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | 2004-03-22 |
| K013251 | SPIRIT 300 | Caire, Inc. | 2001-12-18 |
| K993220 | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | 1999-10-22 |
Legacy Summary#
summary
FDA Review#
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