Cleared Traditional

CADWELL LIMB MOVEMENT MODULE

K040986 · Cadwell Laboratories, Inc. · Neurology
Jul 2004
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K040986 is an FDA 510(k) clearance for the CADWELL LIMB MOVEMENT 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, 77 days after receiving the submission on April 15, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K040986 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2004
Decision Date July 01, 2004
Days to Decision 77 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