TP 1— 510(k) K844483

Substantially Equivalent

Vitatron Medical BV

FDA 510(k) clearance K844483 for TP 1, Substantially Equivalent on 1985-04-19. Applicant: Vitatron Medical BV.

Clearance details

Applicant: Vitatron Medical BV
Product code: Code KRG
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 ↗

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.