SEDECAL X PLUS LP PLUS— 510(k) K062335

Name: FDA 510(k) clearance K062335
Creator: U.S. Food and Drug Administration
Published: 2006-09-14

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K062335 for SEDECAL X PLUS LP PLUS, Substantially Equivalent on 2006-09-14. Applicant: Sedecal., Sa.. Device class: 2.

Clearance details

Applicant: Sedecal., Sa.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2006-08-10
Decision date: 2006-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.