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510(k) K043491

ENFANTTM by Diopsys, Inc. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2005
Date Received
December 17, 2004
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

Other clearances by Diopsys, Inc.

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