510(k) K914309

THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES by Hill-Rom, Inc. — Product Code HDD

K914309 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES". The FDA issued a decision of Substantially Equivalent on April 20, 1992. The device falls under product code HDD (Table, Obstetrical, Ac-Powered (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1992
Date Received
September 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetrical, Ac-Powered (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type