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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intrauterine
510(k) Number K922323
Device Name MX4042/MC4044 SERIES SIMULCATH(TM)
Applicant
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Applicant Contact CATHY CHENETSKI
Correspondent
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Correspondent Contact CATHY CHENETSKI
Regulation Number884.2700
Classification Product Code
KXO  
Date Received05/04/1992
Decision Date 06/14/1994
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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