510(k) K926140

VACUUM POWER BODY FLUID SUCTION APPARATUS by Hill-Rom, Inc. — Product Code KDP

K926140 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "VACUUM POWER BODY FLUID SUCTION APPARATUS". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
December 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type