Cleared Traditional

K063339 - MEDICK MHM200 PERSONAL HEART MONITOR

K063339 is an FDA 510(k) clearance for MEDICK MHM200 PERSONAL HEART MONITOR, manufactured by Medick Healthcare , Ltd.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K063339 · Medick Healthcare , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
235d
Days
Class 2
Risk

K063339 is an FDA 510(k) clearance for the MEDICK MHM200 PERSONAL HEART MONITOR. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Medick Healthcare , Ltd. (Kirkland, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 235 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medick Healthcare , Ltd. devices

FDA 510(k) Submission Details - K063339

510(k) Number K063339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date June 29, 2007
Days to Decision 235 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 125d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 31
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K063339.
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
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DYNAMIC ECG SYSTEM MODEL TLC5000
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3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
K092853 · Galix Biomedical Instrumentation, Inc. · Jul 2010
PREMIER 11 HOLTER
K062088 · Diagnostic Monitoring Software · Aug 2006
MATRIX HOLTER SYSTEM, MODEL M12
K051730 · Global Instrumentation, LLC · Sep 2005
SEER MC
K042782 · Ge Medical Systems Information Technologies · Sep 2005