510(k) K992674— HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A

Substantially Equivalent

Hewlett-Packard GmbH

Clearance details

Applicant: Hewlett-Packard GmbH
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1999-08-10
Decision date: 1999-11-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boeblingen, DE

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.