Cadwell Limb Movement Module

FDA 510(k) K040986 · Cadwell Laboratories, Inc.

Substantially Equivalent

510(k) numberK040986

Submission

Device name
Cadwell Limb Movement Module
Applicant
Cadwell Laboratories, Inc.
Kennewick, WA, US
Received
April 15, 2004
Decision date
July 1, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LEL – Device, Sleep Assessment
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Cadwell Limb Movement Module cleared by the FDA?

Cadwell Limb Movement Module (K040986) received a 510(k) decision of Substantially Equivalent on July 1, 2004, 77 days after the submission was received.

What is the product code of K040986?

The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.