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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K871748
Device Name THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
Applicant
The Buddy Systems, Inc.
C/O Hogan & Hartson
815 Connecticut Ave., NW
Washington,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
The Buddy Systems, Inc.
C/O Hogan & Hartson
815 Connecticut Ave., NW
Washington,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received05/05/1987
Decision Date 06/10/1987
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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