Name: Predicase
Price: 199 USD

K-number	K181676
Device name	Mini Ridge Filter and auxiliary functions for PROBEAT-V
Applicant	Hitachi Ltd. Healthcare Hitachi Works
Product code	LHN
Device class	Class II
Decision date	Aug 15, 2018
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Mini Ridge Filter and auxiliary functions for PROBEAT-V

Everything you need for a 510(k) submission. Nothing you don't.