Cleared Traditional

ISIS MER SYSTEM/ELEKTA MER SYSTEM

K042208 · Inomed Medizintechnik GmbH · Neurology
Mar 2005
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K042208 is an FDA 510(k) clearance for the ISIS MER SYSTEM/ELEKTA MER SYSTEM, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Inomed Medizintechnik GmbH (Stockholm, DE). The FDA issued a Cleared decision on March 18, 2005, 214 days after receiving the submission on August 16, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K042208 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2004
Decision Date March 18, 2005
Days to Decision 214 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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