K-number	K172993
Device name	P20 Series Digital Color Doppler Ultrasound System
Applicant	Sonoscape Medical Corp.
Product code	IYN
Device class	Class II
Decision date	Dec 5, 2017
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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P20 Series Digital Color Doppler Ultrasound System

Everything you need for a 510(k) submission. Nothing you don't.