QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.

System, Imaging, Pulsed Doppler, Ultrasonic

QUANTUM MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Quantum Medical Systems, Inc. with the FDA for Qad Angiodynograph Ultrasound: Color Doppler Eval..

Pre-market Notification Details

Device IDK890998
510k NumberK890998
Device Name:QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah,  WA  98027
ContactTerrence J Sweeney
CorrespondentTerrence J Sweeney
QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah,  WA  98027
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-03
Decision Date1989-05-02

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