510(k) K032143
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2004
- Date Received
- July 14, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Liquid-Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5655
- Review Panel
- AN
- Submission Type