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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K040142
Device Name ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact COLEEN COLEMAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact ELLEN FICKEWIRTH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/22/2004
Decision Date 02/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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