K-number	K213754
Device name	SpiroHome Personal, SpiroHome Clinic
Applicant	Inofab Saglik Teknolojileri A.S
Product code	BZG
Device class	Class II
Decision date	Jun 12, 2023
Decision	Substantially Equivalent
Regulation	868.1840

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Source

View the full FDA submission: accessdata.fda.gov

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SpiroHome Personal, SpiroHome Clinic

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