Cleared Traditional

K880773 - THE VENUS SYSTEM
(FDA 510(k) Clearance)

K880773 · Neuroscientific Corp. · Neurology
Aug 1988
Decision
174d
Days
Class 2
Risk

K880773 is an FDA 510(k) clearance for the THE VENUS SYSTEM, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Neuroscientific Corp. (Farmingdale, US). The FDA issued a Cleared decision on August 18, 1988, 174 days after receiving the submission on February 26, 1988. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K880773 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1988
Decision Date August 18, 1988
Days to Decision 174 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

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