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510(k) K813271

Device
TEMPERATURE PROBES
Applicant
WEBSTER LABORATORIES, INC.
510(k) number
K813271
Product code
KRI  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-29
Date received
1981-11-20
Regulation
870.4200
Classification name
Accessory Equipment, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLC2002-05-03
K992635INTERFACE MODULE IDDDStoeckert Instrumente1999-12-20
K990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert Instrumente1999-11-23
K934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.1993-11-18
K926233CARDIO2 CYCLEErgometrix, Inc.1993-06-04
K922404TUBE GRIPGeorgia Medical Products, Inc.1992-11-23
K892856NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERSAcacia Laboratories, Inc.1989-11-08
K884893CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25American Omni Medical, Inc.1989-01-30
K884640CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700American Omni Medical, Inc.1989-01-24
K874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORMallinckrodt Critical Care1988-02-02
K874925CPE 2000 CARDIO PULMONARY ERGOMETERMedical Graphics Corp.1988-01-19
K864890STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMPShiley, Inc.1987-02-19
K862510STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1Shiley, Inc.1986-07-17
K862549ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HEAmerican Bentley1986-07-15
K860298STABLELINECardio Metrics, Inc.1986-04-02

Legacy Summary#

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FDA Review#

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