510(k) K992504
K992504 is an FDA 510(k) premarket notification submitted by (Ems Sa) Electro Medical Systems for the device "EMS KERMIT". The FDA issued a decision of Substantially Equivalent on January 27, 2000. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. (Ems Sa) Electro Medical Systems has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2000
- Date Received
- July 27, 1999
- 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