Cleared Traditional

MPR2 logO DATALOGGER

K171666 · Raumedic AG · Neurology
Jul 2017
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K171666 is an FDA 510(k) clearance for the MPR2 logO DATALOGGER, 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 July 6, 2017, 31 days after receiving the submission on June 5, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K171666 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2017
Decision Date July 06, 2017
Days to Decision 31 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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