K-number	K202199
Device name	BTL-899ST
Applicant	Btl
Product code	GEI
Device class	Class II
Decision date	Jan 26, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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BTL-899ST

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