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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 K822584
Device Name MULTI-PRONG FETAL SCALP ELECTRODE
Applicant
Kontron Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kontron Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.2675
Classification Product Code
HGP  
Date Received08/26/1982
Decision Date 02/24/1983
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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