FDA · official record K190124Substantially Equivalent

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

Name: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One — FDA K190124
Creator: E.M.S Electro Medical Systems S.A
Keywords: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One, EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One, K190124, ELC, FDA

United StatesELCE.M.S Electro Medical Systems S.A

Verified

Official record identity

FDA application number: K190124
Decision date: October 20, 2019
Published decision: Substantially Equivalent

Classification

Product code: ELC

Published parties

Applicant: E.M.S Electro Medical Systems S.A

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2019-01-25
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4850

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.