AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154— 510(k) K011093

Substantially Equivalent

Agilent Technologies, Inc.

FDA 510(k) clearance K011093 for AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154, Substantially Equivalent on 2001-05-01. Applicant: Agilent Technologies, Inc..

Clearance details

Applicant: Agilent Technologies, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2001-04-10
Decision date: 2001-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.