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510(k) K960097

CHARTR EP by Ics Medical Corp. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1997
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
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)
  • K991497 — ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM (July 28, 1999)
  • K972631 — ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER (September 22, 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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