HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K— 510(k) K990125

Substantially Equivalent

Hewlett-Packard GmbH

FDA 510(k) clearance K990125 for HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K, Substantially Equivalent on 1999-01-29. Applicant: Hewlett-Packard GmbH. Device class: 2.

Clearance details

Applicant
Hewlett-Packard GmbH
Product code
Code DSI
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Boeblingen, DE
Download summary PDFView on FDA.gov ↗

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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, 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.