K-number	K202335
Device name	Ambra ProViewer
Applicant	Dicom Grid Inc Dba Ambra Health
Product code	LLZ
Device class	Class II
Decision date	Sep 4, 2020
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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Ambra ProViewer

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