510(k) K915779

AFFINITY BED MODEL 3600 SERIES by Hill-Rom, Inc. — Product Code KNC

K915779 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "AFFINITY BED MODEL 3600 SERIES". The FDA issued a decision of Substantially Equivalent on February 24, 1993. The device falls under product code KNC (Table, Obstetric (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
February 24, 1993
Date Received
December 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetric (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type