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510(k) Data Aggregation
K Number
K230834Device Name
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
Manufacturer
Date Cleared
2023-11-21
(239 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Trismed Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CARDIPIA800H and CARDIPIA400H are the portable recording device which is to acquire, display, record, and export 12-lead ECG signals and data defined as the electrical heart activity induced on patient skin. ECG are intended to use for adult and pediatic which is defined between 0 and 15 years old by a physician, trained or licensed professionals in a hospital, clinic, medical office, medical use facilities or a prescribed environment under the direction of a physician. CARDIPIA800H and CARDIPIA400H have the resting ECG,12/6-recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. NOTE: ECG should not be used as the patient monitoring system for long term patient monitor.
Device Description
The CARDIPIA800H and CARDIPIA400H consist of main body, power cable. Both devices are intended to be used with 3rd party lead electrodes supplied to a patient by a physician or a monitoring center. High quality FDA cleared lead electrodes should be used. TRISMED's CARDIPIA ECG (model: CARDIPIA800H, CARDIPIA400H) feature the resting ECG, 12/6recording and displaying, 12-lead ECG measurement, and optional export ECG data for hospital information system. CARDIPIA ECG is able to record the standard 12-lead resting ECG with 12, 6 or 3 channel format and any lead combinations of the 12 leads in automatic or manual mode. The preview mode allows to verify the content of the report on the display before printing it. This is useful to avoid printing reports with artifacts or unusable signal. CARDIPIA ECG is freely operated by main AC power without additional adjustment, or by the built-in rechargeable battery which can be used for a limited time in place of AC power. CARDIPIA ECG can save internal memory and export all patient data from USB memory stick or import from USB memory stick to on data management mode.
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