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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Fetal Doppler Ultrasound
510(k) Number K894992
Device Name QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM
Applicant
Quantum Medical Systems, Inc.
1040 12th Ave.
Issaquah,  WA  98027
Applicant Contact TERRENCE J SWEENEY
Correspondent
Quantum Medical Systems, Inc.
1040 12th Ave.
Issaquah,  WA  98027
Correspondent Contact TERRENCE J SWEENEY
Regulation Number884.2660
Classification Product Code
MAA  
Date Received08/08/1989
Decision Date 02/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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