510(k) K040461
K040461 is an FDA 510(k) premarket notification submitted by Medispec, Ltd. for the device "ECONOLITH E3000, MODEL 3000 (SW-6)". The FDA issued a decision of Substantially Equivalent on May 25, 2004. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Medispec, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2004
- Date Received
- February 23, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Extracorporeal Shock-Wave, Urological
- Device Class
- Class II
- Regulation Number
- 876.5990
- Review Panel
- GU
- Submission Type