510(k) K190124 ยท ELC Scaler, Ultrasonic
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
| Applicant | E.M.S Electro Medical Systems S.A, Nyon, CH |
| Decision | Substantially Equivalent, Oct 20, 2019 |
| Received | Jan 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | Electro Medical Systems SA Brand Name: CLEANER BOTTLE
Product Name: CLEANER BOTTLE
Model/Catalog Number: EG-1000
Software Version: N/A
Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW Open, Classified |
ELC | None listed |
| Apr 24, 2024 | Electro Medical Systems SA Brand Name: WATER BOTTLE
Product Name: WATER BOTTLE
Model/Catalog Number: EG-121
Software Version: N/A
Product Description: These bottles are sold empty and are filled by the user with water fort dent Open, Classified |
ELC | None listed |
| Apr 24, 2024 | Electro Medical Systems SA Brand Name: PIEZON Bottle
Product Name: PIEZON Bottle
Model/Catalog Number: EG-111
Software Version: N/A
Product Description: These bottles are sold empty and are filled by the user with water - in so Open, Classified |
ELC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.