K-number	K212529
Device name	Hypotension Decision Assist Model HDA-OR2
Applicant	Directed Systems, Ltd.
Product code	DXG
Device class	Class II
Decision date	Nov 23, 2021
Decision	Substantially Equivalent
Regulation	870.1435

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Source

View the full FDA submission: accessdata.fda.gov

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Hypotension Decision Assist Model HDA-OR2

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