SONOCA 180/195 WOUND CARE SYSTEM— 510(k) K072904

Substantially Equivalent

Soering GmbH

FDA 510(k) clearance K072904 for SONOCA 180/195 WOUND CARE SYSTEM, Substantially Equivalent on 2008-05-21. Applicant: Soering GmbH.

Clearance details

Applicant
Soering GmbH
Product code
Code LFL
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Denton, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LFL

product code LFL
Death
29
Injury
1,046
Malfunction
21,642
Total
22,717

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.