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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 K911657
Device Name FETAL SCALP SPIRAL ELECTRODE
Applicant
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact MICHAEL V SOLOMITA
Correspondent
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact MICHAEL V SOLOMITA
Regulation Number884.2675
Classification Product Code
HGP  
Date Received04/12/1991
Decision Date 07/11/1991
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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