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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, blood-pressure
510(k) Number K811146
Device Name VITA-STAT MODEL 8000-C
Applicant
VITA-STAT
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VITA-STAT
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1110
Classification Product Code
DSK  
Date Received04/27/1981
Decision Date 06/30/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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