DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM— 510(k) K950477

Name: FDA 510(k) clearance K950477
Creator: U.S. Food and Drug Administration
Published: 1995-11-06

Substantially Equivalent

Nikomed U.S.A., Inc.

FDA 510(k) clearance K950477 for DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM, Substantially Equivalent on 1995-11-06. Applicant: Nikomed U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Nikomed U.S.A., Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1995-02-03
Decision date: 1995-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doylestown, PA, US

Download summary PDF View on FDA.gov ↗

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K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM1995-11-14
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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.