CRITERION II PACING SYSTEM MONITORS— 510(k) K802325

Substantially Equivalent

Dart Medical Equipment

FDA 510(k) clearance K802325 for CRITERION II PACING SYSTEM MONITORS, Substantially Equivalent on 1980-10-23. Applicant: Dart Medical Equipment.

Clearance details

Applicant: Dart Medical Equipment
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1980-09-23
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.