CERYX6, 611, CERYX 3 311 & CERYX 1 111— 510(k) K844485

Name: FDA 510(k) clearance K844485
Creator: U.S. Food and Drug Administration
Published: 1985-04-19

Substantially Equivalent

Vitatron Medical BV

FDA 510(k) clearance K844485 for CERYX6, 611, CERYX 3 311 & CERYX 1 111, Substantially Equivalent on 1985-04-19. Applicant: Vitatron Medical BV. Device class: 3.

Clearance details

Applicant: Vitatron Medical BV
Product code: Code KRG
Device class: Class 3
Regulation: 21 CFR 870.3700
Advisory panel: Cardiovascular
Date received: 1984-11-19
Decision date: 1985-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dieren, NL

Download summary PDF View on FDA.gov ↗

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K840668 — ELECTRODE PACEMAKER, PERM & TEMP1984-09-24
K831859 — PACEMAKER PROGRAMMER #20321983-10-27

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.