510(k) K171877
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2017
- Date Received
- June 23, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type