Cleared Special

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION

K130346 · Natus Neurology Incorporated · Neurology

May 2013

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K130346 is an FDA 510(k) clearance for the SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on May 2, 2013, 80 days after receiving the submission on February 11, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number	K130346 FDA.gov
FDA Decision	Cleared 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