MEDICK MHM200 PERSONAL HEART MONITOR— 510(k) K063339

Name: FDA 510(k) clearance K063339
Creator: U.S. Food and Drug Administration
Published: 2007-06-29

Substantially Equivalent

Medick Healthcare , Ltd.

FDA 510(k) clearance K063339 for MEDICK MHM200 PERSONAL HEART MONITOR, Substantially Equivalent on 2007-06-29. Applicant: Medick Healthcare , Ltd.. Device class: 2.

Clearance details

Applicant: Medick Healthcare , Ltd.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2006-11-06
Decision date: 2007-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLO

view all

K261580 — ZBPro Diagnostic (Version 2.0)2026-09-11
K241890 — Philips Holter Analysis System2025-03-21
K240794 — Frontier X Plus2024-11-08
K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System2020-09-02
K193177 — CER-S2020-08-26

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