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510(k) K921878

Device
SCANMATE III
Applicant
CIRCADIAN, INC.
510(k) number
K921878
Product code
IYP  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-11
Date received
1992-04-20
Regulation
892.1370
Classification name
Phantom, Anthropomorphic, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GARY J ALLSEBROOK
Address
16303 Panoramic Way San Leandro CA US 94578 94578

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IYP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844189LINEAR SCANNER PROBE ELSCINT LTD. TL-35Elscint, Inc.1985-02-25
K812893SUPERFLABMick Radio-Nuclear Instruments, Inc.1981-12-08

Legacy Summary#

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FDA Review#

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