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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K003434
Device Name ALLEGRO TB, ALLEGRO N
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact DAVID KOLESAR
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact DAVID KOLESAR
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/06/2000
Decision Date 11/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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