SEDECAL— 510(k) K103522

Name: FDA 510(k) clearance K103522
Creator: U.S. Food and Drug Administration
Published: 2011-01-26

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K103522 for SEDECAL, Substantially Equivalent on 2011-01-26. Applicant: Sedecal., Sa.. Device class: 2.

Clearance details

Applicant: Sedecal., Sa.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2010-12-01
Decision date: 2011-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.