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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Circular (Spiral), Scalp And Applicator
510(k) Number K871079
Device Name FETALFLEX FETAL ELECTRODE
Applicant
Epcom Medical Systems, Inc.
26602 Corporate Ave.
Hayward,  CA  94545
Applicant Contact PAUL ULBRICH
Correspondent
Epcom Medical Systems, Inc.
26602 Corporate Ave.
Hayward,  CA  94545
Correspondent Contact PAUL ULBRICH
Regulation Number884.2675
Classification Product Code
HGP  
Date Received03/18/1987
Decision Date 07/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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