Name: Predicase
Price: 199 USD

K-number	K900805
Device name	ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
Applicant	Ge Medical Systems Information Technologies
Product code	IYO
Device class	Class II
Decision date	Aug 23, 1990
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM

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