510(k) K190124
K190124 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One". The FDA issued a decision of Substantially Equivalent on October 20, 2019. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2019
- Date Received
- January 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type