MEMO Patch M (MPT-E08R-UNC01)— 510(k) K243438

Substantially Equivalent

Huinno Co., Ltd.

FDA 510(k) clearance K243438 for MEMO Patch M (MPT-E08R-UNC01), Substantially Equivalent on 2025-12-05. Applicant: Huinno Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huinno Co., Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2024-11-06
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXH

K250233 — PreemptiveAI Clinical SDK2026-02-13
K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System2025-12-08
K243981 — Hexoskin Medical System (7100-00016)2025-11-18
K243003 — VitalSigns 1-Lead Holter (VSH101)2025-06-17
K233521 — QT ECG (QTERD100)2023-12-06

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