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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K864318
Device Name THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM
Applicant
The Buddy Systems, Inc.
1880 Holste Rd.
Northbrook,  IL  60062
Applicant Contact JAMES A HAYES
Correspondent
The Buddy Systems, Inc.
1880 Holste Rd.
Northbrook,  IL  60062
Correspondent Contact JAMES A HAYES
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/03/1986
Decision Date 03/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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