Cleared Traditional

COMPONENT NEUROMONITORING SYSTEM (K080217) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080217 · Moberg Research, Inc. · Neurology device
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Nov 2008
Decision
281d
Days
Class 2
Risk

K080217 is an FDA 510(k) clearance for the COMPONENT NEUROMONITORING SYSTEM. Classified as Amplitude-integrated Electroencephalograph (product code OMA), Class II - Special Controls.

Submitted by Moberg Research, Inc. (Ambler, US). The FDA issued a Cleared decision on November 5, 2008 after a review of 281 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Moberg Research, Inc. devices

Submission Details

510(k) Number K080217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2008
Decision Date November 05, 2008
Days to Decision 281 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 148d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code OMA Amplitude-integrated Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.