510(k) K210179

QOCA Portable ECG Monitoring Device by Quanta Computer, Inc. — Product Code DSH

K210179 is an FDA 510(k) premarket notification submitted by Quanta Computer, Inc. for the device "QOCA Portable ECG Monitoring Device". The FDA issued a decision of Substantially Equivalent on August 2, 2022. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Quanta Computer, Inc. has at least 4 other 510(k) clearances on record.