HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS— 510(k) K943654
Substantially EquivalentMdt Biologic Co.
FDA 510(k) clearance K943654 for HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS, Substantially Equivalent on 1995-08-02. Applicant: Mdt Biologic Co.. Device class: 2.
Clearance details
- Applicant
- Mdt Biologic Co.
- 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
- Rancho Dominguez, CA, US
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More clearances from Mdt Biologic Co.
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.