Name: Predicase
Price: 199 USD

K-number	K190353
Device name	Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
Applicant	Residential Home Sleep Services
Product code	PLC
Device class	Class II
Decision date	Apr 10, 2020
Decision	Substantially Equivalent
Regulation	872.5570

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

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