510(k) K952447

HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER by Hill-Rom, Inc. — Product Code FPO

K952447 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER". The FDA issued a decision of Substantially Equivalent on November 22, 1995. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1995
Date Received
May 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled
Device Class
Class II
Regulation Number
880.6910
Review Panel
HO
Submission Type