RED DOT 2269 INFANT MONITORING ELECTRODE— 510(k) K902080

Substantially Equivalent

3M Company

FDA 510(k) clearance K902080 for RED DOT 2269 INFANT MONITORING ELECTRODE, Substantially Equivalent on 1990-07-18. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1990-05-08
Decision date: 1990-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cottae Grove, MN, 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.