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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353206239 | K190124 | 000 |
| 07613353198688 | K190124 | 000 |
| 07613353198701 | K190124 | 000 |
| 07613353198244 | K190124 | 000 |
| 07613353198251 | K190124 | 000 |
| 07613353198695 | K190124 | 000 |
| 07613353161958 | K190124 | 000 |
| 07613353161965 | K190124 | 000 |
| 07613353187378 | K190124 | 000 |
| 07613353199739 | K190124 | 000 |
| 07613353207397 | K190124 | 000 |
| 07613353214432 | K190124 | 000 |
| 07613353214449 | K190124 | 000 |
| 07613353185343 | K190124 | 000 |
| 07613353213176 | K190124 | 000 |
| 07613353213183 | K190124 | 000 |
| 07613353209179 | K190124 | 000 |
| 07613353212636 | K190124 | 000 |
| 07613353205089 | K190124 | 000 |
| 07613353187392 | K190124 | 000 |
| 07613353195229 | K190124 | 000 |
| 07613353195243 | K190124 | 000 |
| 07613353157968 | K190124 | 000 |
| 07613353179236 | K190124 | 000 |
| 07613353183929 | K190124 | 000 |
| 07613353183936 | K190124 | 000 |
| 07613353183943 | K190124 | 000 |
| 07613353183950 | K190124 | 000 |
| 07613353184124 | K190124 | 000 |
| 07613353184148 | K190124 | 000 |
| 07613353114909 | K190124 | 000 |
| 07613353114886 | K190124 | 000 |
| 07613353123000 | K190124 | 000 |
| 07613353123017 | K190124 | 000 |
| 07613353134327 | K190124 | 000 |
| 07613353132859 | K190124 | 000 |
| 07613353180546 | K190124 | 000 |
| 07613353183530 | K190124 | 000 |
| 07613353186531 | K190124 | 000 |
| 07613353193515 | K190124 | 000 |
| 07613353196448 | K190124 | 000 |