DeviceClearance

VEO MULTIGAS MONITOR FOR POCKET PC— 510(k) K081601

Substantially Equivalent

Phasein AB

FDA 510(k) clearance K081601 for VEO MULTIGAS MONITOR FOR POCKET PC, Substantially Equivalent on 2008-09-04. Applicant: Phasein AB.

Clearance details

Applicant
Phasein AB
Product code
Code CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Madison, WI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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.