DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES— 510(k) K853038

Substantially Equivalent

Bio-Detek, Inc.

FDA 510(k) clearance K853038 for DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES, Substantially Equivalent on 1986-01-07. Applicant: Bio-Detek, Inc..

Clearance details

Applicant: Bio-Detek, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1985-07-19
Decision date: 1986-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, 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.