Mobile Oxygen Storage Tank (Most)
by Pacific Consolidated Industries Llp United States 510(k)
510(k) K040738
Product code CAW
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040738 | Date30 Apr 2004 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-2201-2008
The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges. With one unit the operator was able to shut off the oxygen flow, however one rupture resulted in a fire. No injuries were reported.
Specification
- 510(k) Number
- FDA Product Code
- CAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5440
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacific Consolidated Industries LLC
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K040738