ENDOSCOPIC CO2 REGULATION UNIT UCR— 510(k) K081173
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K081173 for ENDOSCOPIC CO2 REGULATION UNIT UCR, Substantially Equivalent on 2008-12-23. Applicant: Olympus Medical Systems Corporation.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code HET
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Adverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
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.