EMS PIEZON MASTER 600— 510(k) K022328
Substantially EquivalentElectro Medical Systems SA
FDA 510(k) clearance K022328 for EMS PIEZON MASTER 600, Substantially Equivalent on 2002-08-13. Applicant: Electro Medical Systems SA. Device class: 2.
Clearance details
- Applicant
- Electro Medical Systems SA
- 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
- Special
- Location
- North Attleboro, MA, US
Recent devices under product code ELC
view allMore clearances from Electro Medical Systems SA
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.