DMS 300-2, 300-3 AND 300-4— 510(k) K062959

Substantially Equivalent

Diagnostic Monitoring Software

FDA 510(k) clearance K062959 for DMS 300-2, 300-3 AND 300-4, Substantially Equivalent on 2006-10-16. Applicant: Diagnostic Monitoring Software.

Clearance details

Applicant: Diagnostic Monitoring Software
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2006-09-29
Decision date: 2006-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Stateline, NV, 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.