510(k) K061622
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2007
- Date Received
- June 12, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Image, Illumination, Fiberoptic, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type