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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ballistocardiograph
510(k) Number K863508
Device Name FRANTZ MEDICAL ELECTRODE
Applicant
Frantz Medical Development, Ltd.
595 Madison Ave.
New York,  NY  10022
Applicant Contact MARK G FRANTZ
Correspondent
Frantz Medical Development, Ltd.
595 Madison Ave.
New York,  NY  10022
Correspondent Contact MARK G FRANTZ
Regulation Number870.2320
Classification Product Code
DXR  
Date Received09/09/1986
Decision Date 02/06/1987
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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