Name: Predicase
Price: 199 USD

K-number	K010548
Device name	MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
Applicant	Radionics, A Division of Tyco Healthcare Group LP
Product code	HAW
Device class	Class II
Decision date	Mar 12, 2001
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

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