LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P— 510(k) K050919

Substantially Equivalent

Analogic Corp.

FDA 510(k) clearance K050919 for LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P, Substantially Equivalent on 2005-06-14. Applicant: Analogic Corp..

Clearance details

Applicant: Analogic Corp.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2005-04-12
Decision date: 2005-06-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Peabody, MA, 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.