510(k) K874794
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