K-number	K210166
Device name	Omnispec ED1000
Applicant	Medispec, Ltd.
Product code	ISA
Device class	Class I
Decision date	Jan 27, 2023
Decision	Substantially Equivalent
Regulation	890.5660

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Source

View the full FDA submission: accessdata.fda.gov

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Omnispec ED1000

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