K-number	K241458
Device name	Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
Applicant	Borvo Medical, Inc.
Product code	JXG
Device class	Class II
Decision date	Aug 20, 2024
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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Borvo EVAC System (Ergo); Borvo EVAC System (Classic)

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