DIGITAL AMBULATORY ECG (HOLTER) RECORDER— 510(k) K031074

Substantially Equivalent

Datrix

FDA 510(k) clearance K031074 for DIGITAL AMBULATORY ECG (HOLTER) RECORDER, Substantially Equivalent on 2003-10-15. Applicant: Datrix.

Clearance details

Applicant: Datrix
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2003-04-04
Decision date: 2003-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Escondido, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.