CAAS II— 510(k) K945540

Name: FDA 510(k) clearance K945540
Creator: U.S. Food and Drug Administration
Published: 1995-06-28

Substantially Equivalent

Pie Medical Equipment B.V.

FDA 510(k) clearance K945540 for CAAS II, Substantially Equivalent on 1995-06-28. Applicant: Pie Medical Equipment B.V.. Device class: 2.

Clearance details

Applicant: Pie Medical Equipment B.V.
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 1994-11-14
Decision date: 1995-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.