K-number	K191539
Device name	1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
Applicant	Rapid Biomedical GmbH
Product code	MOS
Device class	Class II
Decision date	Jan 31, 2020
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support

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