EMS AIR-FLOW MASTER PIEZON
FDA 510(k) clearance K110173 · decided 2011-04-07
Clearance details
- K-number
- K110173
- Device name
- EMS AIR-FLOW MASTER PIEZON
- Applicant
- E.M.S Electro Medical Systems S.A
- Decision
- Substantially Equivalent
- Date received
- 2011-01-20
- Decision date
- 2011-04-07
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.