OPTIMA MX— 510(k) K042759
Substantially EquivalentBien-Air SA Switzerland
FDA 510(k) clearance K042759 for OPTIMA MX, Substantially Equivalent on 2004-10-20. Applicant: Bien-Air SA Switzerland. Device class: 1.
Clearance details
- Applicant
- Bien-Air SA Switzerland
- Product code
- Code EIA
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bienne 6, CH
Recent devices under product code EIA
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