Logic Hd camera head green, System green— 510(k) K212808
Substantially EquivalentRichard Wolf Medical Instruments Corporation
FDA 510(k) clearance K212808 for Logic Hd camera head green, System green, Substantially Equivalent on 2022-06-14. Applicant: Richard Wolf Medical Instruments Corporation. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corporation
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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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.