510(k) K972111

RUMORS DYNAMIC AIR THERAPY UNIT by Hill-Rom, Inc. — Product Code IKZ

K972111 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "RUMORS DYNAMIC AIR THERAPY UNIT". The FDA issued a decision of Substantially Equivalent on February 2, 1998. The device falls under product code IKZ (Bed, Patient Rotation, Powered), a Class II device regulated under 21 CFR 890.5225. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1998
Date Received
June 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Patient Rotation, Powered
Device Class
Class II
Regulation Number
890.5225
Review Panel
PM
Submission Type