Cleared Special

K130346 - SYNERGY FOCUS DESKTOP VERSION (FDA 510(k) Clearance)

Also includes:
SYNERGY FOCUS LAPTOP VERSION

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130346 · Natus Neurology Incorporated · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
80d
Days
Class 2
Risk

K130346 is an FDA 510(k) clearance for the SYNERGY FOCUS DESKTOP VERSION. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on May 2, 2013 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natus Neurology Incorporated devices

Submission Details

510(k) Number K130346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2013
Decision Date May 02, 2013
Days to Decision 80 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 148d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 138
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