Cleared Traditional

Polysmith Sleep System

K142774 · Neurotronics, Inc. · Neurology
Feb 2015
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K142774 is an FDA 510(k) clearance for the Polysmith Sleep System, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Neurotronics, Inc. (Gainesville, US). The FDA issued a Cleared decision on February 18, 2015, 145 days after receiving the submission on September 26, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K142774 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2014
Decision Date February 18, 2015
Days to Decision 145 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLV — Standard Polysomnograph With Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.