510(k) K202989
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2021
- Date Received
- September 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Analysis, Anterior Segment
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type