K-number	K223629
Device name	SpiroSphere, SpiroSphereECG, CardioSphere
Applicant	Eresearchtechnology GmbH
Product code	BTY
Device class	Class II
Decision date	May 28, 2024
Decision	Substantially Equivalent
Regulation	868.1890

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View the full FDA submission: accessdata.fda.gov

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SpiroSphere, SpiroSphereECG, CardioSphere

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