AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR— 510(k) K000822

Substantially Equivalent

Agilent Technologies, GmbH

FDA 510(k) clearance K000822 for AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, Substantially Equivalent on 2000-04-06. Applicant: Agilent Technologies, GmbH.

Clearance details

Applicant: Agilent Technologies, GmbH
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2000-03-14
Decision date: 2000-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Boeblingen, DE

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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.