DeviceClearance

DDRELEMENT— 510(k) K110828

Substantially Equivalent

Swissray Medical AG

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

Clearance details

Applicant
Swissray Medical AG
Product code
Code KPR
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
East Brunswick, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KPR

product code KPR
Other
6
Total
6

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.