510(k) K191945
K191945 is an FDA 510(k) premarket notification submitted by Kowa Company , Ltd. for the device "KOWA nonmyd 8". The FDA issued a decision of Substantially Equivalent on September 10, 2019. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Kowa Company , Ltd. has at least 2 other 510(k) clearances on record.
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