THE HOLTER REPORTER (TM)— 510(k) K860249

Substantially Equivalent

Applied Cardiac Systems

FDA 510(k) clearance K860249 for THE HOLTER REPORTER (TM), Substantially Equivalent on 1986-03-11. Applicant: Applied Cardiac Systems.

Clearance details

Applicant: Applied Cardiac Systems
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1986-01-24
Decision date: 1986-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.