510(k) K992251

SWISS LITHOCLAST MULTIPURPOSE PROBE by Electro Medical Systems SA — Product Code FFK

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