510(k) K130288

STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE by Cardiac Insight, Inc. — Product Code DSH

K130288 is an FDA 510(k) premarket notification submitted by Cardiac Insight, Inc. for the device "STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE". The FDA issued a decision of Substantially Equivalent on May 29, 2013. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Cardiac Insight, Inc. has 2 other 510(k) clearances on record.