K-number	K233707
Device name	HFT150
Applicant	Invent Medical Corporation
Product code	BTT
Device class	Class II
Decision date	Jun 14, 2024
Decision	Substantially Equivalent
Regulation	868.5450

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Source

View the full FDA submission: accessdata.fda.gov

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HFT150

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