510(k) K962942

TOTALCARE by Hill-Rom, Inc. — Product Code FNL

K962942 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "TOTALCARE". The FDA issued a decision of Substantially Equivalent on February 3, 1997. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1997
Date Received
July 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Ac-Powered Adjustable Hospital
Device Class
Class II
Regulation Number
880.5100
Review Panel
HO
Submission Type