STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM— 510(k) K924685

Substantially Equivalent

Leibinger GmbH

FDA 510(k) clearance K924685 for STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM, Substantially Equivalent on 1994-09-16. Applicant: Leibinger GmbH.

Clearance details

Applicant: Leibinger GmbH
Product code: Code IYE
Advisory panel: Radiology
Date received: 1992-09-16
Decision date: 1994-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.