Cleared Traditional

EASYNET BODY POSITION MODULE

K040932 · Cadwell Laboratories, Inc. · Neurology
Jul 2004
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K040932 is an FDA 510(k) clearance for the EASYNET BODY POSITION MODULE, a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on July 1, 2004, 83 days after receiving the submission on April 9, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K040932 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2004
Decision Date July 01, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code LEL — Device, Sleep Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050