Name: Predicase
Price: 199 USD

K-number	K212860
Device name	SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
Applicant	STERIS Corporation
Product code	FDI
Device class	Class II
Decision date	Oct 7, 2021
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)

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