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510(k) K902493

Device
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
510(k) number
K902493
Product code
DRI  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-06
Date received
1990-06-05
Regulation
870.2620
Classification name
Monitor, Line Isolation
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
OLLI RIIKKALA
Address
P.O. Box 446 Sf-00101 Helsinki, Finland FI

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K902492CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2SDatex Division Instrumentarium Corp.1990-07-06
K822316HEART MONITOR BRACELET ALARMHmba1982-09-21
K802326PRESSURE MONITORING LINESStanco Medical, Inc.1980-10-10

Legacy Summary#

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FDA Review#

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