EMS AIR-FLOW MASTER PIEZON— 510(k) K110173
Substantially EquivalentE.M.S Electro Medical Systems S.A
FDA 510(k) clearance K110173 for EMS AIR-FLOW MASTER PIEZON, Substantially Equivalent on 2011-04-07. Applicant: E.M.S Electro Medical Systems S.A.
Clearance details
- Applicant
- E.M.S Electro Medical Systems S.A
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
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.