510(k) K191945
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2019
- Date Received
- July 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type