510(k) K092031
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2010
- Date Received
- July 6, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Gas-Scavenging
- Device Class
- Class II
- Regulation Number
- 868.5430
- Review Panel
- AN
- Submission Type