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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K902460
Device Name CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)
Applicant
Oakfield Instruments, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd., Eynsham
Oxon Ox8 1ja England,  GB
Applicant Contact JOHN GIDDINGS
Correspondent
Oakfield Instruments, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd., Eynsham
Oxon Ox8 1ja England,  GB
Correspondent Contact JOHN GIDDINGS
Regulation Number892.1320
Classification Product Code
IZD  
Date Received06/04/1990
Decision Date 08/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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