Cleared Traditional

ASSURE Wearable ECG

K233864 · Kestra Medical Technologies, Inc. · Cardiovascular
May 2024
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K233864 is an FDA 510(k) clearance for the ASSURE Wearable ECG, a Electrocardiograph, Ambulatory (without Analysis) (Class II — Special Controls, product code MWJ), submitted by Kestra Medical Technologies, Inc. (Kirkland, US). The FDA issued a Cleared decision on May 7, 2024, 153 days after receiving the submission on December 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K233864 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2023
Decision Date May 07, 2024
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MWJ — Electrocardiograph, Ambulatory (without Analysis)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800