EVOTECH ECR— 510(k) K152189
Substantially EquivalentAdvanced Sterilization Products (Asp)
FDA 510(k) clearance K152189 for EVOTECH ECR, Substantially Equivalent on 2016-07-20. Applicant: Advanced Sterilization Products (Asp).
Clearance details
- Applicant
- Advanced Sterilization Products (Asp)
- Product code
- Code FEB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Adverse events under product code FEB
product code FEB- Malfunction
- 3,879
- Total
- 3,879
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.