K-number	K190732
Device name	P200TxE
Applicant	Optos Plc.
Product code	OBO
Device class	Class II
Decision date	Jul 31, 2019
Decision	Substantially Equivalent
Regulation	886.1570

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Source

View the full FDA submission: accessdata.fda.gov

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P200TxE

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