AIR-FLOW PLUS Prophylaxis powder
K-Number: K171189 · 2017-09-11
ApplicantE.M.S Electro Medical Systems S.A
Decision Date2017-09-11
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AIR-FLOW PLUS Prophylaxis powder is a medical device manufactured by E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2017-09-11 under approval number K171189. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AIR-FLOW PLUS Prophylaxis powder?
AIR-FLOW PLUS Prophylaxis powder is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by E.M.S Electro Medical Systems S.A. The 510(k) number is K171189.
When was AIR-FLOW PLUS Prophylaxis powder approved by the FDA?
AIR-FLOW PLUS Prophylaxis powder received FDA 510(k) clearance on 2017-09-11, under approval number K171189.
What company makes AIR-FLOW PLUS Prophylaxis powder?
AIR-FLOW PLUS Prophylaxis powder is manufactured by E.M.S Electro Medical Systems S.A.
What is the FDA product code for AIR-FLOW PLUS Prophylaxis powder?
The FDA product code for AIR-FLOW PLUS Prophylaxis powder is EJR.
Other Devices by E.M.S Electro Medical Systems S.A
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.