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FDA 510(k) Application Details - K020800
Device Classification Name
Recorder, Attention Task Performance
More FDA Info for this Device
510(K) Number
K020800
Device Name
Recorder, Attention Task Performance
Applicant
OPTAX SYSTEMS, INC.
7 TIFFANY TRAIL
HOPKINTON, MA 01748 US
Other 510(k) Applications for this Company
Contact
DEBBIE IAMPIETRO
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/2002
Decision Date
06/10/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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