EXTERNAL TEST PULSE GENERATOR— 510(k) K780717

Substantially Equivalent

Vitatron Medical BV

FDA 510(k) clearance K780717 for EXTERNAL TEST PULSE GENERATOR, Substantially Equivalent on 1978-06-30. Applicant: Vitatron Medical BV.

Clearance details

Applicant: Vitatron Medical BV
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1978-04-27
Decision date: 1978-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.