K-number	K241268
Device name	Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
Applicant	Exceleron Medical
Product code	BZE
Device class	Class II
Decision date	Aug 2, 2024
Decision	Substantially Equivalent
Regulation	868.5270

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Source

View the full FDA submission: accessdata.fda.gov

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Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

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