510(k) K050430
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2005
- Date Received
- February 18, 2005
- 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