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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 K895763
Device Name ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING
Applicant
Healthdyne Cardiovascular, Inc.
1579 Sunland Ln.
Costa Mesa,  CA  92626
Applicant Contact BILL WELCH
Correspondent
Healthdyne Cardiovascular, Inc.
1579 Sunland Ln.
Costa Mesa,  CA  92626
Correspondent Contact BILL WELCH
Regulation Number884.2700
Classification Product Code
KXO  
Date Received09/26/1989
Decision Date 12/22/1989
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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