Name: Predicase
Price: 199 USD

K-number	K040719
Device name	ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
Applicant	Aloka Co., Ltd.
Product code	IYO
Device class	Class II
Decision date	Mar 26, 2004
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY

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