Cleared Traditional

RAUMEDIC- ICP-MONITORING SYSTEM

K103206 · Raumedic AG · Neurology
Mar 2011
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K103206 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 March 4, 2011, 123 days after receiving the submission on November 1, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K103206 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2010
Decision Date March 04, 2011
Days to Decision 123 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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