510(k) K071928
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2007
- Date Received
- July 12, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type