K-numberK050006
Device nameBOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
ApplicantC.R. Bard, Inc.
Product codeDRQ
Device classClass II
Decision dateMay 27, 2005
DecisionSubstantially Equivalent
Regulation870.2060
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