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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K901643
Device Name ISOFLO(TM) AMNIOCENTESIS TRAY
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 Number884.1550
Classification Product Code
HIO  
Date Received04/09/1990
Decision Date 07/25/1990
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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