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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K973556
Device Name IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
Applicant
IMEX MEDICAL SYSTEMS, INC.
6355 JOYCE DR.
GOLDEN,  CO  80403
Applicant Contact DAVID W WAGNER
Correspondent
IMEX MEDICAL SYSTEMS, INC.
6355 JOYCE DR.
GOLDEN,  CO  80403
Correspondent Contact DAVID W WAGNER
Regulation Number892.1550
Classification Product Code
IYN  
Date Received09/19/1997
Decision Date 04/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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