Name: Predicase
Price: 199 USD

K-number	K050088
Device name	QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
Applicant	Neoprobe Corp.
Product code	DPW
Device class	Class II
Decision date	Feb 8, 2005
Decision	Substantially Equivalent
Regulation	870.2100

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Source

View the full FDA submission: accessdata.fda.gov

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QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER

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