DDRELEMENT— 510(k) K110828

Name: FDA 510(k) clearance K110828
Creator: U.S. Food and Drug Administration
Published: 2011-08-23

Substantially Equivalent

Swissray Medical AG

FDA 510(k) clearance K110828 for DDRELEMENT, Substantially Equivalent on 2011-08-23. Applicant: Swissray Medical AG. Device class: 2.

Clearance details

Applicant: Swissray Medical AG
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2011-03-24
Decision date: 2011-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Brunswick, NJ, 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.