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510(k) K860469

Device
37-701-1 PATIENT DOASE MONITOR WITH DETECTORS
Applicant
VICTOREEN, INC.
510(k) number
K860469
Product code
KPZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-16
Date received
1986-02-06
Regulation
892.5900
Classification name
Generator, High Voltage, X-ray, Therapeutic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GLASSER
Address
100 Voice Rd. Carle Place NY US 11514 11514

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912249PATIENT DOSE MONITORTheta Systems, Inc.1991-08-30
K854410VERIFLEXOld Delft Corp. of America1986-02-12

Legacy Summary#

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FDA Review#

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