Cleared Traditional

ApneaTrak

K192624 · Cadwell Industries, Inc. · Neurology

Feb 2020

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K192624 is an FDA 510(k) clearance for the ApneaTrak, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on February 20, 2020, 150 days after receiving the submission on September 23, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K192624 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2019
Decision Date	February 20, 2020
Days to Decision	150 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.