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510(k) Data Aggregation
K Number
K063339Device Name
MEDICK MHM200 PERSONAL HEART MONITOR
Manufacturer
MEDICK HEALTHCARE LTD.
Date Cleared
2007-06-29
(235 days)
Product Code
MLO
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
MEDICK HEALTHCARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MHM200 Monitor is intended for in-context monitoring of adult patients where symptoms occur infrequently or where resting ECG monitoring is unlikely to capture symptomatic or asymptomatic abnormal rhythm events.
Its use includes assessing symptoms (including palpitations, dizzy spells, paroxysmal light-headedness, and pounding of the heart) that may relate to disturbances of the heart.
Where it is clinically appropriate, the MHM200 Monitor can assist in ongoing monitoring of the frequency of abnormal rhythm events in patients receiving antiarrhythmic medication or rehabilitation therapy.
Device Description
The Medick MHM200 is an ECG testing device that monitors heart on a beat by beat basis to detect any irregularities. It does this over a period of up to 8 hours and reports a person's heart rhythm. It is small, light weight, portable, single channel ECG ambulatory monitor equipped with an LCD that is used to set-up the monitor and display cardiac information. The monitor is powered by two (2) standard AAA alkaline batteries. The MHM200 can communicate with a computer over a standard USB connection to store and print a person's cardiac information. For safety reasons, the MHM200 uses proprietary patient and USB cables. The cables share a common input connector. The patient cable must be removed before the monitor can be connected to a computer through the USB cable.
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