Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525— 510(k) K200617

Substantially Equivalent

Richard Wolf Medical Instruments Corporation

FDA 510(k) clearance K200617 for Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525, Substantially Equivalent on 2020-06-23. Applicant: Richard Wolf Medical Instruments Corporation.

Clearance details

Applicant
Richard Wolf Medical Instruments Corporation
Product code
Code FET
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Vernon Hills, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FET

product code FET
Injury
313
Malfunction
54,276
Total
54,589

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.