510(k) K920235
K920235 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "ULTRASOUND GENERATOR MODLE 2270". The FDA issued a decision of Substantially Equivalent on December 7, 1992. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1992
- Date Received
- January 17, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 876.4480
- Review Panel
- GU
- Submission Type