Name: Predicase
Price: 199 USD

K-number	K081873
Device name	EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
Applicant	Shenzhen Emperor Electronic Technology Co. , Ltd.
Product code	IYO
Device class	Class II
Decision date	Jul 16, 2008
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE

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