SORING GMBH SONOCA 180/190— 510(k) K012753

Substantially Equivalent

Soring GmbH Medizintechnik

FDA 510(k) clearance K012753 for SORING GMBH SONOCA 180/190, Substantially Equivalent on 2001-11-13. Applicant: Soring GmbH Medizintechnik.

Clearance details

Applicant: Soring GmbH Medizintechnik
Product code: Code LFL
Advisory panel: Unknown
Date received: 2001-08-16
Decision date: 2001-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.