Vacuum Power Body Fluid Suction Apparatus

FDA 510(k) K926140 · Hill-Rom, Inc.

Substantially Equivalent

510(k) numberK926140

Submission

Device name
Vacuum Power Body Fluid Suction Apparatus
Applicant
Hill-Rom, Inc.
Batesville, TN, US
Received
December 7, 1992
Decision date
July 27, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KDP – Regulator, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Specialty
General Hospital

Other 510(k)s with product code KDP

510(k)DeviceApplicantDecision
K013976Boehringer MRI Suction RegulatoryKDP · Traditional Boehringer Laboratories01/08/2002SE
K944479PM3300 Intermittent VacuumKDP · Traditional Precision Medical, Inc.12/22/1994SE
K942747Malcolm-Lynn(Tm) Eot Suction Reg Valve(Tm) (SRV) )KDP · Traditional Engineered Orthopedic Technologies, Inc.07/21/1994SE
K933232Boehringer Laboratories Suction Regulator, ModifiedKDP · Traditional Boehringer Laboratories03/28/1994SE
K922817PM3000 & PM3100 Vacuum RegulatorKDP · Traditional Precision Medical, Inc.03/04/1993SE
K883229Ohmeda Continuous Suction RegulatorKDP · Traditional Ohmeda Medical10/19/1988SE
K875074Vacumate Intermittent/Continuous CONTROLLER,VM2000KDP · Traditional Timeter Instrument Corp.02/22/1988SE
K853155Boehringer Lab Suction InterrupterKDP · Traditional Boehringer Laboratories10/16/1985SE
K850200Suction Regulator 7700 SeriesKDP · Traditional Boehringer Laboratories03/04/1985SE
K843591InterceptKDP · Traditional Vital Signs, Inc.10/19/1984SE

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Questions and answers

When was Vacuum Power Body Fluid Suction Apparatus cleared by the FDA?

Vacuum Power Body Fluid Suction Apparatus (K926140) received a 510(k) decision of Substantially Equivalent on July 27, 1993, 232 days after the submission was received.

What is the product code of K926140?

The FDA product code is KDP – Regulator, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.