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510(k) K013976

Device
BOEHRINGER MRI SUCTION REGULATORY
Applicant
Boehringer Laboratories
510(k) number
K013976
Product code
KDP
Decision
Substantially Equivalent (SESE)
Decision date
2002-01-08
Date received
2001-12-03
Regulation
880.6740
Classification name
Regulator, Vacuum
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
JOHN KARPOWICZ
Address
500 E. Washington St. Norristown PA US 19401 19401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944479PM3300 INTERMITTENT VACUUMPrecision Medical, Inc.1994-12-22
K942747MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )Engineered Orthopedic Technologies, Inc.1994-07-21
K933232BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIEDBoehringer Laboratories1994-03-28
K926140VACUUM POWER BODY FLUID SUCTION APPARATUSHill-Rom, Inc.1993-07-27
K922817PM3000 & PM3100 VACUUM REGULATORPrecision Medical, Inc.1993-03-04
K883229OHMEDA CONTINUOUS SUCTION REGULATOROhmeda Medical1988-10-19
K875074VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000Timeter Instrument Corp.1988-02-22
K853155BOEHRINGER LAB SUCTION INTERRUPTERBoehringer Laboratories1985-10-16
K850200SUCTION REGULATOR 7700 SERIESBoehringer Laboratories1985-03-04
K843591INTERCEPTVital Signs, Inc.1984-10-19
K834224VACUUM REGULATOR 0-2000 MMHG VR-1000Trimeter Instrument Corp.1984-02-27
K831505THORACIC GAUGE #TG-60 -VACUUM REGULATORSorensen Research1983-07-12
K830343CONTAINER W/PRIMING SOLUTIONAmerican Hospital Supply Corp.1983-03-17
K821314FEVER METERSteridyne Corp.1982-05-28
K820706WATERLESS SEAL & VACUUM REGULATORSorensen Research1982-04-09