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510(k) Data Aggregation
K Number
K061123Device Name
PALM ECG RECORDER, MODEL EP-201/202
Manufacturer
Date Cleared
2007-06-29
(431 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
PARAMA-TECH COMPANY., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Palm ECG Recorder™ Model EP-201C/202C is intended for self-testing and home health care use. The Palm ECG Recorder™ Model EP-201C/202C records, stores and transfier ECG waveforms, R-R graph and average heart rate data and presents these cardiological events in a synchronized time scale for interpretation by a physician trained in such an analysis. This is a prescription device for use only under the direction of a physician. A software user infare allows viewing. This screening tool is not intended for use as a diagnostic tool ar as a subtitute for a hospital diagnostic ECG device. This device is not intended for simulaneously recording and transmission of a user's ECG signal. This device is not recommended for use with in planted pacemakers.
Device Description
The Palm ECG Recorder™, Model EP-201C/202C, is made by Parama-Tech Co., Ltd. This wireless ECG Monitor is portable, non-invasive and handheld. This is a Class II device that measures and displays EGC waveforms, R-R graph, an average heart rate along with comments. Once this device is prescribed by a physician, the Palm ECG Recorder "", can be used anytime, anywhere by anyone. This devices allows acquisition and transmission of ECG data from the user to a personal computer.
This device is suitable to detect transient symptoms that may suggest abnormal cardiac conditions to monitor cardiac conditions on a daily basis. This device is ideally suited for health care.
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