NeoBeat, NeoBeat Mini— 510(k) K232111

Name: FDA 510(k) clearance K232111
Creator: U.S. Food and Drug Administration
Published: 2024-06-25

Substantially Equivalent

Laerdal Medical AS

FDA 510(k) clearance K232111 for NeoBeat, NeoBeat Mini, Substantially Equivalent on 2024-06-25. Applicant: Laerdal Medical AS. Device class: 2.

Clearance details

Applicant: Laerdal Medical AS
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2023-07-14
Decision date: 2024-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stavanger, NO

Download summary PDF View on FDA.gov ↗

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K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

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K183348 — Reusable Silicone Cover CPRmeter 22018-12-17
K173886 — CPRmeter 2 CPR Feedback Device2018-03-23
K151702 — Reusable Full Silicone Cover2015-08-13

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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