HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300— 510(k) K911615

Substantially Equivalent

Diagnostic Monitoring Software

FDA 510(k) clearance K911615 for HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300, Substantially Equivalent on 1992-01-08. Applicant: Diagnostic Monitoring Software.

Clearance details

Applicant: Diagnostic Monitoring Software
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1991-04-11
Decision date: 1992-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.