SINGLE BED ARRHYTHMIA MONITOR AM500— 510(k) K831638

Substantially Equivalent

Lifeline Systems, Inc.

FDA 510(k) clearance K831638 for SINGLE BED ARRHYTHMIA MONITOR AM500, Substantially Equivalent on 1983-11-14. Applicant: Lifeline Systems, Inc..

Clearance details

Applicant: Lifeline Systems, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1983-05-23
Decision date: 1983-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.