STERRAD 100NX Sterilizer with ALLClear Technology— 510(k) K212174
Substantially EquivalentAdvanced Sterilization Products, Inc.
FDA 510(k) clearance K212174 for STERRAD 100NX Sterilizer with ALLClear Technology, Substantially Equivalent on 2021-10-09. Applicant: Advanced Sterilization Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Sterilization Products, Inc.
- Product code
- Code MLR
- Device class
- Class 2
- Regulation
- 21 CFR 880.6860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
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More clearances from Advanced Sterilization Products, Inc.
view allAdverse 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.