DM-400 HOLTER ECG CASSETTE RECORDER— 510(k) K970298

Substantially Equivalent

Diagnostic Monitoring

FDA 510(k) clearance K970298 for DM-400 HOLTER ECG CASSETTE RECORDER, Substantially Equivalent on 1997-08-20. Applicant: Diagnostic Monitoring.

Clearance details

Applicant: Diagnostic Monitoring
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1997-01-27
Decision date: 1997-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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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.