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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K862381
Device Name FUTUREMED ECG SYSTEM 500
Applicant
Futuremed Div. of Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Applicant Contact MORAD DAVOUDZADEH
Correspondent
Futuremed Div. of Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Correspondent Contact MORAD DAVOUDZADEH
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/24/1986
Decision Date 07/17/1986
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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