510(k) K082038

CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V by Clarus Medical, LLC — Product Code BTR

K082038 is an FDA 510(k) premarket notification submitted by Clarus Medical, LLC for the device "CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V". The FDA issued a decision of Substantially Equivalent on April 28, 2009. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Clarus Medical, LLC has at least 9 other 510(k) clearances on record.