510(k) K041924

HAUSTED POWERTRAN SERIES STRETCHER by STERIS Corporation — Product Code INK

K041924 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "HAUSTED POWERTRAN SERIES STRETCHER". The FDA issued a decision of Substantially Equivalent on September 9, 2004. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2004
Date Received
July 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled, Powered
Device Class
Class II
Regulation Number
890.3690
Review Panel
PM
Submission Type