K-number	K843891
Device name	DOPSCAN PLUS DS1060
Applicant	Carolina Medical Electronics
Product code	IYO
Device class	Class II
Decision date	Jan 9, 1985
Decision	Substantially Equivalent
Regulation	892.1560

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View the full FDA submission: accessdata.fda.gov

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DOPSCAN PLUS DS1060

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