Cleared Traditional

DCM (PW-DCM)

K243513 · Pneumowave, Ltd. · Neurology
Apr 2025
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K243513 is an FDA 510(k) clearance for the DCM (PW-DCM), a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Pneumowave, Ltd. (Eurocentral, GB). The FDA issued a Cleared decision on April 16, 2025, 155 days after receiving the submission on November 12, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K243513 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date April 16, 2025
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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