AIR-FLOW handy 3.0 PLUS
FDA 510(k) K151912 · E.M.S Electro Medical Systems S.A
510(k) numberK151912
Submission
- Device name
- AIR-FLOW handy 3.0 PLUS
- Applicant
- E.M.S Electro Medical Systems S.A
Nyon, CH - Received
- July 13, 2015
- Decision date
- February 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was AIR-FLOW handy 3.0 PLUS cleared by the FDA?
AIR-FLOW handy 3.0 PLUS (K151912) received a 510(k) decision of Substantially Equivalent on February 3, 2016, 205 days after the submission was received.
What is the product code of K151912?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.