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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multivariate Vital Signs Index
510(k) Number K843905
Device Name TRAUMA CARE EVALUATION
Applicant
Quantitative
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Quantitative
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2300
Classification Product Code
PLB  
Date Received10/03/1984
Decision Date 09/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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