AIR-FLOW handy 3.0 PLUS
K-Number: K151912 · 2016-02-03
ApplicantE.M.S Electro Medical Systems S.A
Decision Date2016-02-03
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AIR-FLOW handy 3.0 PLUS is a medical device manufactured by E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2016-02-03 under approval number K151912. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AIR-FLOW handy 3.0 PLUS?
AIR-FLOW handy 3.0 PLUS is a medical device that received FDA 510(k) clearance on 2016-02-03. It is manufactured by E.M.S Electro Medical Systems S.A. The 510(k) number is K151912.
When was AIR-FLOW handy 3.0 PLUS approved by the FDA?
AIR-FLOW handy 3.0 PLUS received FDA 510(k) clearance on 2016-02-03, under approval number K151912.
What company makes AIR-FLOW handy 3.0 PLUS?
AIR-FLOW handy 3.0 PLUS is manufactured by E.M.S Electro Medical Systems S.A.
What is the FDA product code for AIR-FLOW handy 3.0 PLUS?
The FDA product code for AIR-FLOW handy 3.0 PLUS is EFB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.