EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD
FDA 510(k) clearance K061414 · decided 2007-01-22
Clearance details
- K-number
- K061414
- Device name
- EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD
- Applicant
- Pacific Consolidated Industries, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-05-22
- Decision date
- 2007-01-22
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Riverside, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 79308 recall (Z-2201-2008) | Pacific Consolidated Industries LLC | 2008-08-28 |