Cleared Traditional

MEMO Patch M (MPT-E08R-UNC01)

K243438 · Huinno Co., Ltd. · Cardiovascular

Dec 2025

Decision

394d

Days

Class 2

Risk

About This 510(k) Submission

K243438 is an FDA 510(k) clearance for the MEMO Patch M (MPT-E08R-UNC01), a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by Huinno Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 5, 2025, 394 days after receiving the submission on November 6, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K243438 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2024
Decision Date	December 05, 2025
Days to Decision	394 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF