510(k) Report

Devices descending from K050006

2 later devices reach Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150235CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II…Boston Scientific Corporation201511
+2K152693CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II…Boston Scientific Corporation20150—