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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 K003458
Device Name SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
Applicant
Clinical Innovations, Inc.
6477 S. Cottonwood St.
Murray,  UT  84107
Applicant Contact DEAN WALLACE
Correspondent
Clinical Innovations, Inc.
6477 S. Cottonwood St.
Murray,  UT  84107
Correspondent Contact DEAN WALLACE
Regulation Number884.2675
Classification Product Code
HGP  
Date Received11/07/2000
Decision Date 05/03/2001
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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