MODEL 5600B PROGRAMMER, PACEMAKER— 510(k) K871986

Name: FDA 510(k) clearance K871986
Creator: U.S. Food and Drug Administration
Published: 1987-06-24

Substantially Equivalent

Telectronics, Inc.

FDA 510(k) clearance K871986 for MODEL 5600B PROGRAMMER, PACEMAKER, Substantially Equivalent on 1987-06-24. Applicant: Telectronics, Inc.. Device class: 3.

Clearance details

Applicant: Telectronics, Inc.
Product code: Code KRG
Device class: Class 3
Regulation: 21 CFR 870.3700
Advisory panel: Cardiovascular
Date received: 1987-05-22
Decision date: 1987-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffield, CT, 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.