510(k) K061330
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2006
- Date Received
- May 12, 2006
- Clearance Type
- Abbreviated
- 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