HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION— 510(k) K990476

Substantially Equivalent

Hewlett-Packard GmbH

FDA 510(k) clearance K990476 for HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION, Substantially Equivalent on 1999-07-22. Applicant: Hewlett-Packard GmbH.

Clearance details

Applicant
Hewlett-Packard GmbH
Product code
Code MHX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boeblingen, DE
Download summary PDFView 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, through . 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.