K-numberK163283
Device nameHAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
ApplicantHamilton Medical AG
Product codeBTT
Device classClass II
Decision dateSep 20, 2017
DecisionSubstantially Equivalent
Regulation868.5450
AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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