510(k) K831939

TALL FLOOR STAND TFS-01 by Sorensen Research — Product Code GCX

K831939 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "TALL FLOOR STAND TFS-01". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Sorensen Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type