510(k) K920235

ULTRASOUND GENERATOR MODLE 2270 by Richard Wolf Medical Instruments Corp. — Product Code FEO

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