DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
FDA 510(k) clearance K130068 · decided 2013-07-19
Clearance details
- K-number
- K130068
- Device name
- DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
- Applicant
- Essex Industries, Inc. D/B/A Essex Cryogenics of M
- Decision
- Substantially Equivalent
- Date received
- 2013-01-11
- Decision date
- 2013-07-19
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- BYJ
- Device class
- 2
- Regulation number
- 868.5655
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MOUNTED MEDICAL OXYGEN SYSTEM (K113767) | Essex Industries, Inc. | 2012-06-29 |
| PRECISION LIQUID OXYGEN SYSTEM (K103324) | Precision Medical, Inc. | 2011-04-21 |
| MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (K101272) | Essex Industries, Inc. | 2010-08-20 |
| GOLOX-93 (K081779) | Respironics, Inc. | 2008-09-19 |
| MODIFICATION TO: SPIRIT (K080023) | Caire, Inc. | 2008-06-16 |
| RESPIRONICS GOLOX (K072723) | Respironics, Inc. | 2008-03-20 |
| COPD LIQUID OXYGEN PORTABLE, MODEL 300P (K072011) | Copd Partners, Inc. | 2007-10-18 |
| BACKPACK MEDICAL OXYGEN SYSTEM (K071581) | Essex Cryogenics of Missouri, Inc. | 2007-07-11 |
| SPIRIT, MODEL HAS (K050153) | Caire, Inc. | 2005-04-15 |
| PLIX (K050414) | Respironics, Inc. | 2005-04-11 |
| PRECISION LIQUID OXYGEN SYSTEM (K041122) | Precision Medical, Inc. | 2004-10-04 |
| LIQUID OXYGEN SYSTEM (K032143) | Micro Technology Services, Inc. | 2004-03-30 |
Recalls involving this device
No recalls on record reference this clearance.