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510(k) K991497

ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM by Ics Medical Corp. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1999
Date Received
April 29, 1999
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

Other clearances by Ics Medical Corp.

  • K031986 — ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS (July 24, 2003)
  • K013060 — ICS MEDICAL MODEL VG-30 VIDEO GOGGLES (December 10, 2001)
  • K011181 — ICS MEDICAL CHARTR OAE WITH TYMP (June 25, 2001)
  • K002985 — ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS (December 13, 2000)
  • K972631 — ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER (September 22, 1997)
  • K960097 — CHARTR EP (February 21, 1997)
  • K931609 — CHARTR ENG SYSTEM (September 26, 1995)
  • K931608 — NCA-200 (June 22, 1993)
  • K925237 — AUTOMATIC CALORIC IRRIGATION SYSTEM (May 5, 1993)
  • K881630 — AUTOMATIC CALORIC IRRIGATION SYSTEM (June 21, 1988)

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