MCI - CMF System— 510(k) K182758
Substantially EquivalentMci Medical Concept Innovation, Inc.
FDA 510(k) clearance K182758 for MCI - CMF System, Substantially Equivalent on 2019-12-05. Applicant: Mci Medical Concept Innovation, Inc..
Clearance details
- Applicant
- Mci Medical Concept Innovation, Inc.
- Product code
- Code JEY
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunrise, FL, US
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
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.