K-number	K240779
Device name	Vivo 3
Applicant	Breas Medical AB
Product code	MNT
Device class	Class II
Decision date	Dec 13, 2024
Decision	Substantially Equivalent
Regulation	868.5895

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Vivo 3

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