510(k) K971307

AMSCO SURGICAL TABLE by STERIS Corporation — Product Code FQO

K971307 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "AMSCO SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on June 27, 1997. 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
June 27, 1997
Date Received
April 8, 1997
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