510(k) K063519
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2006
- Date Received
- November 21, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Apparatus, Gas-Scavenging
- Device Class
- Class II
- Regulation Number
- 868.5430
- Review Panel
- AN
- Submission Type