510(k) K170082
K170082 is an FDA 510(k) premarket notification submitted by The Tova Company for the device "Test of Variables of Attention (T.O.V.A.) Version 9.0". The FDA issued a decision of Substantially Equivalent on May 17, 2017. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device. The Tova Company has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2017
- Date Received
- January 10, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Attention Task Performance
- Device Class
- Class U
- Regulation Number
- Review Panel
- NE
- Submission Type