AIR-FLOW MASTER STANDARD— 510(k) K073284
Substantially Equivalent(Ems Sa) Electro Medical Systems
FDA 510(k) clearance K073284 for AIR-FLOW MASTER STANDARD, Substantially Equivalent on 2007-12-14. Applicant: (Ems Sa) Electro Medical Systems.
Clearance details
- Applicant
- (Ems Sa) Electro Medical Systems
- Product code
- Code EFB
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- North Attleboro, MA, US
Adverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
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.