K-number	K170967
Device name	Intraskan DC Plus
Applicant	Skanray Technologies Private Limited
Product code	EHD
Device class	Class II
Decision date	Jun 8, 2017
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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Intraskan DC Plus

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