Sterilucent HC 80TT Hydrogen Peroxide Sterilizer— 510(k) K190005
Substantially EquivalentSterilucent, Inc.
FDA 510(k) clearance K190005 for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer, Substantially Equivalent on 2019-09-13. Applicant: Sterilucent, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilucent, 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
- Minneapolis, MN, US
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More clearances from Sterilucent, Inc.
view all- K192001 — Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
- K191999 — Sterilucent VH2O2 Chemical Indicators
- K142109 — STERILUCENT STERILIZATION CONTAINER SYSTEM
- K141238 — STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
- K140464 — STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
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.