FDA 510(k)

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

Número K: K190124 · 2019-10-20

RequerenteE.M.S Electro Medical Systems S.A

Data da decisão2019-10-20

Código do produtoELC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2019-10-20 under 510(k) number K190124. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K190124.

When did EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One receive FDA 510(k) clearance?

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One received FDA 510(k) clearance on 2019-10-20, under 510(k) number K190124.

Who is the listed applicant for EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

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.

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