510(k) K050006

BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO by C.R. Bard, Inc. — Product Code DRQ

K050006 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO". The FDA issued a decision of Substantially Equivalent on May 27, 2005. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.