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510(k) K832828

Device
CENTURION CARDIAC DETECTOR
Applicant
CLINICAL DATA INSTRUMENTS, INC.
510(k) number
K832828
Product code
DRJ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-09
Date received
1983-08-19
Regulation
870.2600
Classification name
System, Signal Isolation
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822590PRESSURE ISOLATION AMPLIFIER #9813 517Honeywell, Inc.1982-10-04
K771684AMPLIFIER MODEL N5A-ECGHoneywell, Inc.1977-09-14
K771685AMPLIFIER MODEL N5A-HISHoneywell, Inc.1977-09-14

Legacy Summary#

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FDA Review#

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