Cleared Traditional

NeoBeat, NeoBeat Mini

K232111 · Laerdal Medical AS · Cardiovascular

Jun 2024

Decision

347d

Days

Class 2

Risk

About This 510(k) Submission

K232111 is an FDA 510(k) clearance for the NeoBeat, NeoBeat Mini, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Laerdal Medical AS (Stavanger, NO). The FDA issued a Cleared decision on June 25, 2024, 347 days after receiving the submission on July 14, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K232111 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2023
Decision Date	June 25, 2024
Days to Decision	347 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300