Name: Predicase
Price: 199 USD

K-number	K160343
Device name	SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
Applicant	Beijing East Whale Imaging Technology Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Apr 7, 2016
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner

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