Name: Predicase
Price: 199 USD

K-number	K182281
Device name	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
Applicant	C. R. Bard
Product code	IYO
Device class	Class II
Decision date	Oct 24, 2018
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech

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