510(k) K073190
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2008
- Date Received
- November 13, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type