RMI ULTRASOUND DOPPLER PHANTOM SYSTEM

Block, Test, Ultrasonic Scanner Calibration

RADIATION MEASUREMENTS, INC.

The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Rmi Ultrasound Doppler Phantom System.

Pre-market Notification Details

Device IDK893216
510k NumberK893216
Device Name:RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
ClassificationBlock, Test, Ultrasonic Scanner Calibration
Applicant RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton,  WI  53562
ContactMarie Jennaro
CorrespondentMarie Jennaro
RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton,  WI  53562
Product CodeGXX  
CFR Regulation Number882.1925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-27
Decision Date1989-09-05

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