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510(k) Data Aggregation
K Number
K972587Device Name
ELECTROCARDIOGRAPHS
Manufacturer
Date Cleared
1998-08-21
(406 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DR. LEE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
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K Number
K972603Device Name
ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B
Manufacturer
Date Cleared
1998-03-11
(243 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
DR. LEE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
non-interpretive electrocardiographs
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