EMS PIEZON MASTER 600— 510(k) K022328

Substantially Equivalent

Electro Medical Systems SA

FDA 510(k) clearance K022328 for EMS PIEZON MASTER 600, Substantially Equivalent on 2002-08-13. Applicant: Electro Medical Systems SA.

Clearance details

Applicant
Electro Medical Systems SA
Product code
Code ELC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
North Attleboro, MA, US
Download summary PDFView on FDA.gov ↗

Adverse 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.