510(k) K200275
K200275 is an FDA 510(k) premarket notification submitted by Ophthalmic Labs, Inc. for the device "OVision Imaging System". The FDA issued a decision of Substantially Equivalent on March 3, 2020. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2020
- Date Received
- February 4, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type