510(k) K040894
K040894 is an FDA 510(k) premarket notification submitted by Qbtech AB for the device "QBTEST". The FDA issued a decision of Substantially Equivalent on June 22, 2004. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device. Qbtech AB has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2004
- Date Received
- April 6, 2004
- 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