AAA Model

System, Image Processing, Radiological

Philips Ultrasound, Inc

The following data is part of a premarket notification filed by Philips Ultrasound, Inc with the FDA for Aaa Model.

Pre-market Notification Details

Device IDK200603
510k NumberK200603
Device Name:AAA Model
ClassificationSystem, Image Processing, Radiological
Applicant Philips Ultrasound, Inc 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
ContactHebe Sun
CorrespondentHebe Sun
Philips Ultrasound, Inc 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-09-20

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.