The following data is part of a premarket notification filed by E.m.s Electro Medical Systems S.a. with the FDA for Ems Airflow Prophylaxis Master, Ems Airflow One.
Device ID | K190124 |
510k Number | K190124 |
Device Name: | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One |
Classification | Scaler, Ultrasonic |
Applicant | E.M.S Electro Medical Systems S.A. Chemin De La Vuarpilliere 31 Nyon, CH Ch-1260 |
Contact | Gaelle Pacaud |
Correspondent | Christina Henza Ultra LifeScience Solutions Inc. 872 S. Milwaukee Ave Libertyville, IL 60048 |
Product Code | ELC |
CFR Regulation Number | 872.4850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-25 |
Decision Date | 2019-10-20 |