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510(k) K931609

CHARTR ENG SYSTEM by Ics Medical Corp. — Product Code GWM

K931609 is an FDA 510(k) premarket notification submitted by Ics Medical Corp. for the device "CHARTR ENG SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 1995. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Ics Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1995
Date Received
April 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
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)
  • K960097 — CHARTR EP (February 21, 1997)
  • 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 GWM

  • K252241 — Pressio 3 Multi-parameter Neuromonitoring System (April 10, 2026)
  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (July 18, 2024)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K201989 — B4C System (October 8, 2021)
  • K210993 — CereLink ICP Monitor (April 30, 2021)
  • K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex (May 26, 2020)
  • K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage a (April 9, 2020)
  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)

FDA data resources