510(k) K112502

PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 by Hill-Rom Co. — Product Code INK

K112502 is an FDA 510(k) premarket notification submitted by Hill-Rom Co. for the device "PROCEDURAL STRECHER WITH INTELLIDRIVE P8000". The FDA issued a decision of Substantially Equivalent on September 19, 2011. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690. Hill-Rom Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2011
Date Received
August 30, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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