XENON LIGHT SOURCE MODEL 5121— 510(k) K952696
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K952696 for XENON LIGHT SOURCE MODEL 5121, Substantially Equivalent on 1995-07-25. Applicant: Richard Wolf Medical Instruments Corp..
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code GCT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Adverse events under product code GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
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.