DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC— 510(k) K850132

Substantially Equivalent

Consolidated Medical Equipment, Inc.

FDA 510(k) clearance K850132 for DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC, Substantially Equivalent on 1985-04-09. Applicant: Consolidated Medical Equipment, Inc..

Clearance details

Applicant: Consolidated Medical Equipment, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1985-01-14
Decision date: 1985-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, 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.