STERRAD® NX Sterilizer with ALLClear Technology— 510(k) K160818
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K160818 for STERRAD® NX Sterilizer with ALLClear Technology, Substantially Equivalent on 2016-09-27. Applicant: Advanced Sterilization Products.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- Code MLR
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code MLR
product code MLR- Malfunction
- 805
- Total
- 805
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.