510(k) K012445
K012445 is an FDA 510(k) premarket notification submitted by Electro Medical Systems SA for the device "EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)". The FDA issued a decision of Substantially Equivalent on August 24, 2001. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Electro Medical Systems SA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2001
- Date Received
- August 1, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Electro-Hydraulic
- Device Class
- Class II
- Regulation Number
- 876.4480
- Review Panel
- GU
- Submission Type