1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES— 510(k) K945836

Substantially Equivalent

Conmed Andover Medical, Inc.

FDA 510(k) clearance K945836 for 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES, Substantially Equivalent on 1995-06-20. Applicant: Conmed Andover Medical, Inc..

Clearance details

Applicant: Conmed Andover Medical, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1994-11-29
Decision date: 1995-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haverhill, MA, US

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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.