Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound

System, Imaging, Pulsed Echo, Ultrasonic

THE PROMETHEUS GROUP

The following data is part of a premarket notification filed by The Prometheus Group with the FDA for Morpheus Realtime Ultrasound, Pathway Realtime Ultrasound, Quickscan Bladder Ultrasound.

Pre-market Notification Details

Device IDK160792
510k NumberK160792
Device Name:Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant THE PROMETHEUS GROUP 1 WASHINGTON STREET SUITE 303 Dover,  NH  03820
ContactJoshua Bird
CorrespondentJoshua Bird
THE PROMETHEUS GROUP 1 WASHINGTON STREET SUITE 303 Dover,  NH  03820
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-23
Decision Date2016-04-15
Summary:summary

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