510(k) K121531
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2012
- Date Received
- May 24, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type