Name: Predicase
Price: 199 USD

K-number	K013562
Device name	AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE
Applicant	Baxter Healthcare Corp
Product code	KDI
Device class	Class II
Decision date	Dec 12, 2002
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

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