ULTRA SOFTWARE MODULE: MODEL 2016— 510(k) K863046

Substantially Equivalent

Cardiac Pacemakers, Inc.

FDA 510(k) clearance K863046 for ULTRA SOFTWARE MODULE: MODEL 2016, Substantially Equivalent on 1986-12-05. Applicant: Cardiac Pacemakers, Inc..

Clearance details

Applicant: Cardiac Pacemakers, Inc.
Product code: Code KRG
Advisory panel: Cardiovascular
Date received: 1986-08-12
Decision date: 1986-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code KRG

product code KRG

Malfunction: 8,377
Total: 8,377

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.