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K Number
K972587
Device Name
ELECTROCARDIOGRAPHS
Manufacturer
DR. LEE CO., LTD.
Date Cleared
1998-08-21

(406 days)

Product Code
LOS
Regulation Number
N/A
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Dr.LEE ECG-310A (with interpretive software) is to be used to process the electrical signal transmitted through electrodes and to produce a visual display of the electrical signal produced by the heart. While the Dr.LEE ECG-310A is capable of interpreting the ECG waveform as an aid, it is not intended to replace the review and interpretation by the physician. To be used under professional healthcare supervision.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Dr. Lee ECG-310A, which confirms its substantial equivalence to a predicate device. It specifies the intended use and regulatory classification but does not include specifics about performance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

N/A