510(k) K220929
K220929 is an FDA 510(k) premarket notification submitted by Merit Cro, Inc. for the device "Excelsior". The FDA issued a decision of Substantially Equivalent on October 31, 2022. 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
- October 31, 2022
- Date Received
- March 31, 2022
- 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