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510(k) K912249

Device
PATIENT DOSE MONITOR
Applicant
THETA SYSTEMS, INC.
510(k) number
K912249
Product code
KPZ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-30
Date received
1991-05-21
Regulation
892.5900
Classification name
Generator, High Voltage, X-ray, Therapeutic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KEVIN RUSSELL
Address
6425 Anderson Way Melbourne FL US 32940 32940

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K86046937-701-1 PATIENT DOASE MONITOR WITH DETECTORSVictoreen, Inc.1986-04-16
K854410VERIFLEXOld Delft Corp. of America1986-02-12

Legacy Summary#

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FDA Review#

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