EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
K-Number: K190124 · 2019-10-20
ApplicantE.M.S Electro Medical Systems S.A
Decision Date2019-10-20
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is a medical device manufactured by E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2019-10-20 under approval number K190124. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One?
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is a medical device that received FDA 510(k) clearance on 2019-10-20. It is manufactured by E.M.S Electro Medical Systems S.A. The 510(k) number is K190124.
When was EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One approved by the FDA?
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One received FDA 510(k) clearance on 2019-10-20, under approval number K190124.
What company makes EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One?
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is manufactured by E.M.S Electro Medical Systems S.A.
What is the FDA product code for EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One?
The FDA product code for EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is ELC.
Other Devices by E.M.S Electro Medical Systems S.A
Related Devices (Code: ELC)
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.