50S TRINGA ULTRASOUND IMAGING SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

PIE MEDICAL

The following data is part of a premarket notification filed by Pie Medical with the FDA for 50s Tringa Ultrasound Imaging System.

Pre-market Notification Details

Device IDK020112
510k NumberK020112
Device Name:50S TRINGA ULTRASOUND IMAGING SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant PIE MEDICAL 8000 CASTLEWAY DR. Indianapolis,  IN  46250
ContactColleen Densmore
CorrespondentColleen Densmore
PIE MEDICAL 8000 CASTLEWAY DR. Indianapolis,  IN  46250
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-11
Decision Date2002-04-19
Summary:summary

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