Cleared Traditional

K080217 - COMPONENT NEUROMONITORING SYSTEM

K080217 is an FDA 510(k) clearance for COMPONENT NEUROMONITORING SYSTEM, manufactured by Moberg Research, Inc.. The device is a Class 2 Neurology device with product code OMA cleared through the Traditional 510(k) pathway after a 281-day FDA review.

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

FDA 510(k) Submission Details - K080217

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.

OMA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OMA Amplitude-integrated Electroencephalograph

All 12
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