RED DOT CARDIAC SENSOR SYSTEM— 510(k) K896155

Substantially Equivalent

3M Company

FDA 510(k) clearance K896155 for RED DOT CARDIAC SENSOR SYSTEM, Substantially Equivalent on 1989-12-13. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1989-10-24
Decision date: 1989-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cottae Grove, MN, US

Download summary PDF View on FDA.gov ↗

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.