Cleared Traditional

G.USBAMP

K060803 · G.Tec Medical Engineering GmbH · Neurology
May 2006
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K060803 is an FDA 510(k) clearance for the G.USBAMP, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AT). The FDA issued a Cleared decision on May 2, 2006, 39 days after receiving the submission on March 24, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K060803 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2006
Decision Date May 02, 2006
Days to Decision 39 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835