510(k) K200422
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 2020
- Date Received
- February 20, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type