AIR FLOW SII
FDA 510(k) clearance K900709 · decided 1990-04-18
Clearance details
- K-number
- K900709
- Device name
- AIR FLOW SII
- Applicant
- Electro Medical Systems (Ems Sa)
- Decision
- Substantially Equivalent
- Date received
- 1989-11-30
- Decision date
- 1990-04-18
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Nyon, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| EMS-SWISS DOLORCLAST (P050004/S001) | Electro Medical Systems (Ems Sa) | 2009-08-28 |
| EMS SWISS DOLORCLAST (P050004) | Electro Medical Systems (Ems Sa) | 2007-05-08 |