Cleared Traditional

K931609 - CHARTR ENG SYSTEM
(FDA 510(k) Clearance)

K931609 · Ics Medical Corp. · Neurology
Sep 1995
Decision
908d
Days
Class 2
Risk

K931609 is an FDA 510(k) clearance for the CHARTR ENG SYSTEM. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM).

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on September 26, 1995, 908 days after receiving the submission on April 1, 1993.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K931609 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1993
Decision Date September 26, 1995
Days to Decision 908 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

Similar Devices — GWM Device, Monitoring, Intracranial Pressure

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NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL
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