510(k) K023525

RETISCAN, RETIPORT by Roland Consult — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2004
Date Received
October 21, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type