DMS 300-7— 510(k) K062007

Substantially Equivalent

Diagnostic Monitoring Software

FDA 510(k) clearance K062007 for DMS 300-7, Substantially Equivalent on 2006-08-16. Applicant: Diagnostic Monitoring Software.

Clearance details

Applicant: Diagnostic Monitoring Software
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2006-07-17
Decision date: 2006-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Stateline, NV, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.