Cleared Traditional

POLYSMITH SLEEP SYSTEM, MODEL NTI5498

K062943 · Neurotronics, Inc. · Neurology
May 2007
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K062943 is an FDA 510(k) clearance for the POLYSMITH SLEEP SYSTEM, MODEL NTI5498, a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLZ), submitted by Neurotronics, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 9, 2007, 223 days after receiving the submission on September 28, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K062943 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2006
Decision Date May 09, 2007
Days to Decision 223 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User