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510(k) K023525

RETISCAN, RETIPORT by Roland Consult — Product Code GWE

K023525 is an FDA 510(k) premarket notification submitted by Roland Consult for the device "RETISCAN, RETIPORT". The FDA issued a decision of Substantially Equivalent on March 26, 2004. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890.

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

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FDA data resources