STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER— 510(k) K140464

Substantially Equivalent

Sterilucent, Inc.

FDA 510(k) clearance K140464 for STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER, Substantially Equivalent on 2014-10-31. Applicant: Sterilucent, Inc..

Clearance details

Applicant: Sterilucent, Inc.
Product code: Code MLR
Advisory panel: General Hospital
Date received: 2014-02-24
Decision date: 2014-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code MLR

product code MLR

Malfunction: 805
Total: 805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.