Cleared Traditional

RAUMEDIC ICP MONITORING SYSTEM

K112017 · Raumedic AG · Neurology
Oct 2011
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K112017 is an FDA 510(k) clearance for the RAUMEDIC ICP MONITORING SYSTEM, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Raumedic AG (Helmbrechts, DE). The FDA issued a Cleared decision on October 11, 2011, 89 days after receiving the submission on July 14, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K112017 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2011
Decision Date October 11, 2011
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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

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