CARDIOSTAT 1 ECG RECORDER— 510(k) K844392

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K844392 for CARDIOSTAT 1 ECG RECORDER, Substantially Equivalent on 1985-04-11. Applicant: Siemens Elema AB.

Clearance details

Applicant: Siemens Elema AB
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1984-11-13
Decision date: 1985-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.