Home / 510(k) Clearances / K031986

510(k) K031986

ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS by Ics Medical — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2003
Date Received
June 27, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Ics Medical

  • 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)
  • 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)

Other clearances for product code EWO

  • K234095 — OtoNova/OtoNova Pro (June 21, 2024)
  • K240430 — Otoport Pro (March 15, 2024)
  • K231545 — hearOAE (October 27, 2023)
  • K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, Na (June 22, 2022)
  • K191372 — Lyra (July 15, 2019)
  • K180287 — GSI Corti (May 11, 2018)
  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)