510(k) K964223

CLINITRON RITE-HITE by Hill-Rom, Inc. — Product Code INX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1997
Date Received
October 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type