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510(k) K013060

ICS MEDICAL MODEL VG-30 VIDEO GOGGLES by Ics Medical — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2001
Date Received
September 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

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  • K925237 — AUTOMATIC CALORIC IRRIGATION SYSTEM (May 5, 1993)
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