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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 K901084
Device Name ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
Applicant
Healthdyne Cardiovascular, Inc.
45 Parker St., Suite A
Irvine,  CA  92618
Applicant Contact BILL WELCH
Correspondent
Healthdyne Cardiovascular, Inc.
45 Parker St., Suite A
Irvine,  CA  92618
Correspondent Contact BILL WELCH
Regulation Number884.2700
Classification Product Code
KXO  
Date Received03/07/1990
Decision Date 06/01/1990
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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