510(k) K874794

E600B FOOTSWITCH by Valleylab, Inc. — Product Code BWA

K874794 is an FDA 510(k) premarket notification submitted by Valleylab, Inc. for the device "E600B FOOTSWITCH". The FDA issued a decision of Substantially Equivalent on December 14, 1987. The device falls under product code BWA (Unit, Electrosurgical And Coagulation, With Accessories), a Class II device regulated under 21 CFR 878.4400. Valleylab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1987
Date Received
November 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical And Coagulation, With Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type