K-number	DEN200018
Device name	eXciteOSA with remote and eXciteOSA without remote
Applicant	Signifier Medical Technologies
Product code	QNO
Device class	Class II
Decision date	Feb 5, 2021
Decision	Not Substantially Equivalent
Regulation	872.5575

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Source

View the full FDA submission: accessdata.fda.gov

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eXciteOSA with remote and eXciteOSA without remote

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