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510(k) K022304

ACCUMAP AUTOMATIC PERIMETER by Objectivision Pty , Ltd. — Product Code GWE

K022304 is an FDA 510(k) premarket notification submitted by Objectivision Pty , Ltd. for the device "ACCUMAP AUTOMATIC PERIMETER". The FDA issued a decision of Substantially Equivalent on November 14, 2003. 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
November 14, 2003
Date Received
July 16, 2002
Clearance Type
Traditional
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