510(k) K210396
K210396 is an FDA 510(k) premarket notification submitted by Topcon Healthcare Solutions EMEA Oy for the device "Harmony Referral System". The FDA issued a decision of Substantially Equivalent on September 13, 2021. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Topcon Healthcare Solutions EMEA Oy has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2021
- Date Received
- February 10, 2021
- 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