DISPOSABLE MONITORING ELECTRODES— 510(k) K041954

Name: FDA 510(k) clearance K041954
Creator: U.S. Food and Drug Administration
Published: 2004-09-15

Substantially Equivalent

Shanghai Intco Electrode Manufacturing Co., Ltd.

FDA 510(k) clearance K041954 for DISPOSABLE MONITORING ELECTRODES, Substantially Equivalent on 2004-09-15. Applicant: Shanghai Intco Electrode Manufacturing Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Intco Electrode Manufacturing Co., Ltd.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 2004-07-20
Decision date: 2004-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandpoint, ID, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.