510(k) K190056
K190056 is an FDA 510(k) premarket notification submitted by Kowa Co. Ltd. Chofu for the device "KOWA VK-2s". The FDA issued a decision of Substantially Equivalent on February 12, 2019. 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
- February 12, 2019
- Date Received
- January 11, 2019
- 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