Piezon Built-in Kit, Piezon Built-in Kit LED— 510(k) K191079
Substantially EquivalentE.M.S Electro Medical Systems S.A
FDA 510(k) clearance K191079 for Piezon Built-in Kit, Piezon Built-in Kit LED, Substantially Equivalent on 2019-08-16. Applicant: E.M.S Electro Medical Systems S.A. Device class: 2.
Clearance details
- Applicant
- E.M.S Electro Medical Systems S.A
- Product code
- Code ELC
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nyon, CH
Recent devices under product code ELC
view allMore clearances from E.M.S Electro Medical Systems S.A
view allAdverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
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.