ST/AR ST AND ARRHYTHMIA SOFTWARE— 510(k) K001348

Substantially Equivalent

Agilent Technologies, Inc.

FDA 510(k) clearance K001348 for ST/AR ST AND ARRHYTHMIA SOFTWARE, Substantially Equivalent on 2000-05-17. Applicant: Agilent Technologies, Inc..

Clearance details

Applicant: Agilent Technologies, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2000-04-28
Decision date: 2000-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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.