DeviceClearance

IVAC PC ANIFUSER— 510(k) K915063

Substantially Equivalent

Y

FDA 510(k) clearance K915063 for IVAC PC ANIFUSER, Substantially Equivalent on 1992-06-03. Applicant: Y.

Clearance details

Applicant
Y
Product code
Code MEA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MEA

product code MEA
Death
19
Malfunction
25,089
Total
25,108

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.