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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K973090
Device Name MEDSTATION
Applicant
PROGRAM S.R.L.
719 CATALPA AVE.
TEANECK,  NJ  07666
Applicant Contact DIANA UPTON
Correspondent
PROGRAM S.R.L.
719 CATALPA AVE.
TEANECK,  NJ  07666
Correspondent Contact DIANA UPTON
Regulation Number892.2020
Classification Product Code
LMD  
Date Received08/18/1997
Decision Date 10/28/1997
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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