DCM (PW-DCM)— 510(k) K243513

Substantially Equivalent

Pneumowave, Ltd.

FDA 510(k) clearance K243513 for DCM (PW-DCM), Substantially Equivalent on 2025-04-16. Applicant: Pneumowave, Ltd.. Device class: 2.

Clearance details

Applicant: Pneumowave, Ltd.
Product code: Code LEL
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2024-11-12
Decision date: 2025-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eurocentral, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.