PACEMAKER PROGRAMMER #2010— 510(k) K811217

Name: FDA 510(k) clearance K811217
Creator: U.S. Food and Drug Administration
Published: 1981-07-20

Substantially Equivalent

Cardiac Pacemakers, Inc.

FDA 510(k) clearance K811217 for PACEMAKER PROGRAMMER #2010, Substantially Equivalent on 1981-07-20. Applicant: Cardiac Pacemakers, Inc.. Device class: 3.

Clearance details

Applicant: Cardiac Pacemakers, Inc.
Product code: Code KRG
Device class: Class 3
Regulation: 21 CFR 870.3700
Advisory panel: Cardiovascular
Date received: 1981-05-04
Decision date: 1981-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.