Cleared Traditional

K172312 - eego amplifiers (FDA 510(k) Clearance)

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

K172312 · Eemagine Medical Imaging Solutions GmbH · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2018
Decision
241d
Days
Class 2
Risk

K172312 is an FDA 510(k) clearance for the eego amplifiers. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Eemagine Medical Imaging Solutions GmbH (Berlin, DE). The FDA issued a Cleared decision on March 30, 2018 after a review of 241 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Eemagine Medical Imaging Solutions GmbH devices

Submission Details

510(k) Number K172312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date March 30, 2018
Days to Decision 241 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 148d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 52
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