CRITERION II PACING SYSTEM MONITORS— 510(k) K800286

Substantially Equivalent

Dart Medical Equipment

FDA 510(k) clearance K800286 for CRITERION II PACING SYSTEM MONITORS, Substantially Equivalent on 1980-03-12. Applicant: Dart Medical Equipment.

Clearance details

Applicant: Dart Medical Equipment
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1980-02-08
Decision date: 1980-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.