510(k) K971390

QUANTUM 3080SP SURGICAL TABLE by STERIS Corporation — Product Code GDC

K971390 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "QUANTUM 3080SP SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on May 15, 1997. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1997
Date Received
April 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Electrical
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type