HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS— 510(k) K943654

Substantially Equivalent

Mdt Biologic Co.

FDA 510(k) clearance K943654 for HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS, Substantially Equivalent on 1995-08-02. Applicant: Mdt Biologic Co..

Clearance details

Applicant: Mdt Biologic Co.
Product code: Code MLR
Advisory panel: General Hospital
Date received: 1994-07-28
Decision date: 1995-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Dominguez, CA, 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.