510(k) K152890
K152890 is an FDA 510(k) premarket notification submitted by Ober Consulting Sp. Z.O.O. for the device "SACCADOMETER PLUS, SACCADOMETER ADVANCED". The FDA issued a decision of Substantially Equivalent on August 11, 2016. The device falls under product code HLL (Monitor, Eye Movement), a Class II device regulated under 21 CFR 886.1510.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2016
- Date Received
- September 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Eye Movement
- Device Class
- Class II
- Regulation Number
- 886.1510
- Review Panel
- OP
- Submission Type