ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B— 510(k) K972603

Name: FDA 510(k) clearance K972603
Creator: U.S. Food and Drug Administration
Published: 1998-03-11

Substantially Equivalent

Dr. Lee Co., Ltd.

FDA 510(k) clearance K972603 for ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B, Substantially Equivalent on 1998-03-11. Applicant: Dr. Lee Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dr. Lee Co., Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1997-07-11
Decision date: 1998-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.