Device Type ID | 3837 |
Device Name | Recorder, Attention Task Performance |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
Submission Type | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | LQD |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3837 |
Device | Recorder, Attention Task Performance |
Product Code | LQD |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
ANTHROTRONIX, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QBTECH AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
THE TOVA COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 2 |