Cleared Traditional

Sleepware G3

K202142 · Respironics, Inc. · Neurology
Oct 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K202142 is an FDA 510(k) clearance for the Sleepware G3, a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLZ), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 29, 2020, 90 days after receiving the submission on July 31, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K202142 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2020
Decision Date October 29, 2020
Days to Decision 90 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