Name: Predicase
Price: 199 USD

K-number	K131906
Device name	SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
Applicant	Satelec - Acteon Group
Product code	EBZ
Device class	Class II
Decision date	Apr 11, 2014
Decision	Substantially Equivalent
Regulation	872.6070

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Source

View the full FDA submission: accessdata.fda.gov

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SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE

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