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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K912615
Device Name ROCHE COBAS ARGOS 5 DIFF
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Applicant Contact CAROL L KRIEGER
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Correspondent Contact CAROL L KRIEGER
Regulation Number882.5810
Classification Product Code
GZI  
Date Received06/13/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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