510(k) K022328
K022328 is an FDA 510(k) premarket notification submitted by Electro Medical Systems SA for the device "EMS PIEZON MASTER 600". The FDA issued a decision of Substantially Equivalent on August 13, 2002. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Electro Medical Systems SA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2002
- Date Received
- July 18, 2002
- Clearance Type
- Special
- 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