Cleared Traditional

K172312 - eego amplifiers

K172312 is an FDA 510(k) clearance for eego amplifiers, manufactured by Eemagine Medical Imaging Solutions GmbH. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K172312 · Eemagine Medical Imaging Solutions GmbH · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K172312

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
Combination Product No
PCCP Authorized No
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.

GWL Device Classification - Class 2, Special Controls

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 Consultant

Quality & Regulatory Associates, LLC
Gary J. Syring

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWL Amplifier, Physiological Signal

All 18
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K172312.
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