510(k) K161829
K161829 is an FDA 510(k) premarket notification submitted by Huvitz Co., Ltd. for the device "Huvitz Imaging System". The FDA issued a decision of Substantially Equivalent on April 6, 2017. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Huvitz Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2017
- Date Received
- July 5, 2016
- 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