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510(k) K822590

Device
PRESSURE ISOLATION AMPLIFIER #9813 517
Applicant
HONEYWELL, INC.
510(k) number
K822590
Product code
DRJ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-10-04
Date received
1982-09-07
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
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 DRJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832828CENTURION CARDIAC DETECTORClinical Data Instruments, Inc.1984-05-09
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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