510(k) K992251
K992251 is an FDA 510(k) premarket notification submitted by Electro Medical Systems SA for the device "SWISS LITHOCLAST MULTIPURPOSE PROBE". The FDA issued a decision of Substantially Equivalent on July 27, 1999. 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
- July 27, 1999
- Date Received
- July 6, 1999
- 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