510(k) K191000

Carnation Ambulatory Monitor by Bardy Diagnostics, Inc. — Product Code DSH

K191000 is an FDA 510(k) premarket notification submitted by Bardy Diagnostics, Inc. for the device "Carnation Ambulatory Monitor". The FDA issued a decision of Substantially Equivalent on May 16, 2019. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Bardy Diagnostics, Inc. has at least 6 other 510(k) clearances on record.