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510(k) K864703

Device
MODIFIED GAS-STAT(TM) MONITORING SYSTEM
Applicant
CARDIOVASCULAR DEVICES, INC.
510(k) number
K864703
Product code
DTY  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-19
Date received
1986-12-02
Regulation
870.4410
Classification name
Sensor, Blood-gas, In-line, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEHRICH, PHD
Address
2801 Barranca Irvine CA US 92714 92714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093650BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEMMedtronic, Inc.2010-02-17
K963698CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4International Biophysics Corp.1997-03-20
K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMMedtronic Bio-Medicus, Inc.1996-01-16
K902654CDI (TM) SYSTEM 100 MONITORING SYSTEM3M Health Care, Ltd.1990-11-05
K900860PERFUSION MONITORCardio Metrics, Inc.1990-08-14
K840749GAST STAT MONITORING SYSTEMCardiovascular Devices, Inc.1984-04-17
K822000EXTRACORPOREAL BLOOD GAS SYSTEMCardiovascular Devices, Inc.1982-12-22

Legacy Summary#

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FDA Review#

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