DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37— 510(k) K860546

Name: FDA 510(k) clearance K860546
Creator: U.S. Food and Drug Administration
Published: 1986-04-23

Substantially Equivalent

Pacesetter Systems

FDA 510(k) clearance K860546 for DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37, Substantially Equivalent on 1986-04-23. Applicant: Pacesetter Systems. Device class: 3.

Clearance details

Applicant: Pacesetter Systems
Product code: Code KRG
Device class: Class 3
Regulation: 21 CFR 870.3700
Advisory panel: Cardiovascular
Date received: 1986-02-13
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, 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.