510(k) K090136

STERIS CMAX XLT SURGICAL TABLE by STERIS Corporation — Product Code FQO

K090136 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "STERIS CMAX XLT SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on March 20, 2009. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), 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
March 20, 2009
Date Received
January 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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