(243 days)
Dr. LEE ECG-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart.
The patient population is any patient requiring an electrocardiograph at the direction of a physician.
The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.
non-interpretive electrocardiographs
This document is a 510(k) premarket notification letter from the FDA to Dr. Lee Co., Ltd. for Electrocardiographs Models 110B, 120B, and 310B. It states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, detailed device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It focuses on the regulatory approval process and indications for use.
Therefore, I cannot provide the requested information based on the provided text.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).