K-number	K240919
Device name	Silk Voice (SMI-04)
Applicant	Sofregen Medical
Product code	MIX
Device class	Class II
Decision date	May 3, 2024
Decision	Substantially Equivalent
Regulation	874.3620

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Source

View the full FDA submission: accessdata.fda.gov

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Silk Voice (SMI-04)

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